Právní předpis byl sestaven k datu 01.10.2003.
Zobrazené znění právního předpisu je účinné od 01.10.2003 do 30.03.2015.
Vyhláška, kterou se mění vyhláška č. 501/2000 Sb., kterou se stanoví formy, způsoby ohlašování nežádoucích příhod zdravotnických prostředků, jejich evidování, šetření a vyhodnocování, dokumentace a její uchovávání a následné sledování s cílem předcházení vzniku nežádoucích příhod, zejména jejich opakování (vyhláška o nežádoucích příhodách zdravotnických prostředků)
304/2003 Sb.
304
XXXXXXXX
xx xxx 3. xxxx 2003,
xxxxxx xx mění xxxxxxxx x. 501/2000 Xx., xxxxxx xx xxxxxxx xxxxx, způsoby ohlašování xxxxxxxxxxx příhod xxxxxxxxxxxxxx xxxxxxxxxx, xxxxxx evidování, xxxxxxx a xxxxxxxxxxxxx, xxxxxxxxxxx x xxxx xxxxxxxxxx x xxxxxxxx xxxxxxxxx s xxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxxx, xxxxxxx xxxxxx xxxxxxxxx (xxxxxxxx x xxxxxxxxxxx xxxxxxxxx zdravotnických xxxxxxxxxx)
Xxxxxxxxxxxx xxxxxxxxxxxxx stanoví xxxxx §34 zákona č. 123/2000 Xx., x xxxxxxxxxxxxxx xxxxxxxxxxxx a x xxxxx xxxxxxxxxxxxx xxxxxx:
Xx. X
Xxxxxxx x. 1 x 2 x xxxxxxxx č. 501/2000 Sb., xxxxxx xx stanoví xxxxx, xxxxxxx ohlašování xxxxxxxxxxx xxxxxx xxxxxxxxxxxxxx xxxxxxxxxx, xxxxxx xxxxxxxxx, xxxxxxx x vyhodnocování, xxxxxxxxxxx x xxxx uchovávání x xxxxxxxx xxxxxxxxx x xxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxxx, xxxxxxx jejich xxxxxxxxx (xxxxxxxx x xxxxxxxxxxx xxxxxxxxx zdravotnických xxxxxxxxxx), xxxxx:
"Xxxxxxx x. 1 x xxxxxxxx x. 501/2000 Sb.
Xxxxxxxx I
xxx xxxxx hlášení nežádoucí xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx
Xxxxxxxx Initiral Xxxxxx Xxxx
Xxxxxx x xxxxxxx nežádoucí xxxxxxx
Xxxxx xx xxxxxxxxx xxxxxxxx
Xxxxxxx musí xxx podáno xxxxxxxxxx, x xxxx nejsou x xxxxxxxxx všechny xxxxxxxx xxxxxxxxx.
The xxxxxx xxxxxx be xxxx as xxxx xx xxxxxxxx xxxx xx xxx xxx xxx xxxxxxxxxxx necessary xxx the xxxxxxxxxx xx the xxxx xx xxxxxxxxx.
2100 | Xxxxxxxxx xxxx provádějící xxxxxxx xxxxxxxxx příhody / Instituion xxxxxxxxx xxxxxxx xxxxxxxx Kód xxxxxxxxxxx xxxxx / Xxxx xx competent xxxxxxxxx XX/XX02 | ||
2110 | Xxxxx xxxxxxxxxxx xxxxx / Xxxx xx xxxxxxxxx xxxxxxxxx Státní xxxxx xxx xxxxxxxx xxxxx (xxxx xxx „XXXX“) | ||
2120 | Xxxxx, xxxxx xxxx a/nebo xxxxxxxx xxxxxxxx / Xxxxxx, xxxxx number xxx/xx XX xxx Xxxxxxxxx 48 | ||
2130 | XXX / Xxxxxx xxxx 100 41 | 2140 | Xxxx / Xxxx Xxxxx 10 |
2150 | Telefon / Xxxxxxxxx xxxxxx 272&xxxx;185&xxxx;780, 272&xxxx;185&xxxx;705 | 2160 | Xxx / Xxx number 272&xxxx;185&xxxx;764 |
2170 | X-Xxxx xxxx@xxxx.xx | 2180 | Xxxx / Xxxxxxx CZ |
2190 | Xxxxxxx xxx XXXX xx subjektu, xxxxx xxxxx xxxxxxxxx xxxxxxx / Xxxxxx to XXXX xx xxxxxxx xxxxxxxxxx initial xxxxxxxx Xxxxx xxxxxxxx, který xxxxxx zprávu / Xxxx of xxxxxxx xxxxxxxxxx xxxxxx | ||
2195 | Xxx subjektu / Xxxx of xxxxxxx1) | ||
2200 | Xxxxxxx / Manufacturer Xxxxxxxx / Xxxx Xxxxxxxxxxxx xxxxxxxx / Authorized xxxxxxxxxxxxxx2) Xxxxxxx / Xxxxx Xxxxxxx / Xxxxxxxx | ||
2210 | Xxxxx, xxxxx xxxx x/xxxx xxxxxxxx xxxxxxxx / Xxxxxx, xxxxx xxxxxx xxx/xx XX xxx | ||
2220 | XXX / Xxxxxx code | 2230 | Xxxx / Xxxx |
2240 | Xxx xxxxx / Xxxxxxx xxxx3) | 2250 | Xxx xxxxx / Xxxxxx code4) |
2260 | Xxxxx xxxxxxxxx osoby / Name xx xxxxxxx xxxxxx5) | ||
2270 | Telefon / Xxxxxxxxx xxxxxx | 2280 | Xxx / Xxx number |
2290 | X-Xxxx | 2230 | Datum xxxxxxx / Xxxx xx xxxxxx6) |
2305 | Xxxxx xxxxxxxxx xxxxxxx (přiděluje XXXX) Xxxxxxxx xxxxxx (xxxxxxxxxx xxxxxx xxxxxxxx xx XXXX) CZ/CA02/..... | ||
2310 | Xxxxxxxxxxxx xxxxxxxxxx / Xxxxxxx xxxxxx Xxxxx xxxxxxxxxxxxxx prostředku / Xxxxxxxxxx xxxx of xxxxxxx device |
2320 | Xxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx XXXXX / GMDN7) UMDS / XXXX xxxx xx xxxxxxx xxxxxx |
2330 | Xxxxx skupiny xxxxxxxxxxxxxx prostředku xxxxx xxxxx UMDNS / XXXX (xxxx. kardiostimulátory, xxxxxx xxxxxxxxxx)7) XXXXX / XXXX designation xx medical device xx Xxxxx (x.x. Xxxxxxxxxx, Xxxxxxx, Xxxxxxxx Xxxxxxxxxxx) |
2335 | Xxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx8) Xxxxxxxx xx medical xxxxxx |
2340 | Modelové xxxx xxxxxxxxxxx číslo xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxx or catalogue xxxxxx |
2350 | Xxxxx(x) xxxxx xxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxx(x) or xxx xxxxxx(x) |
2360 | Xxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx / xxxxxxxxxxxxx (xxxxxxxx xx součástí)9) Xxxxxxxxxx medical xxxxxxx / xxxxxxxxxxx (xx xxxxxxxxxx) |
2370 | Verze xxxxxxxxxxxx vybavení (xxxxxxxx xx xxxxxxxx)9) Xxxxxxxx xxxxxxx (if xxxxxxxxxx) |
2380 | Xxxxxxx / Xxxxxxxxxxxx Xxx xxxxxxx / Xxxx xx manufacturer1) |
2390 | Xxxxx výrobce / Xxxx xx xxxxxxxxxxxx5) |
2400 | Identifikační xxxxx xxxxxxxxxxxx osoby, xxxxx xxxxx xxxxxxxxx. Xxxxxxxxxxxxxx xxxxxx xx Xxxxxxxx Body xxxxxxxx xx xxxxxxxxxx xxxxxxxxxx. XX/XX...... |
2410 | Xxxxxx xxxxx xxxxxxx již xxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx typu? Xxx the xxxxxxxxx xxxx xxxxxxxxxx xxxxxxxx xxxxxxxx involving this xxxxxxx xxxxxx? xxx / xxx xx / xx |
2420 | Xxxxx xxxxxxx dřívější xxxxxxxxx xxxxxxx / Xxxx xx xxxxxx of xxxxxxx xxxxxxxx6) |
2430 | Xxxxxxxx ano, xxx xx xxxxx xxxx (ze xxxx XX, kde se xxxxxxxxxxxx xxxxxxxxxx xxxxxxx)2) Xx yes, to xxxxx xxxxxxx (other XXX xxxxxxxxx xxxxx xxx medical device xx on xxxx) XX XX XX XX ES XX XX XX XX XX XX IT XX XX NL XX XX XX |
2440 | Xxxxxxx xxxxxxx / Xxxxxx xx manufacturer Xxxxxxx xxxxxxx xxxxxx (xxxxxxxx, xxxxxxxxx xxxxx, xxxx zdroj):10) Xxxxxx xx xxxxxxxxxxxx xx (xxxx, contact person xx other xxxxxx): |
2450 | Xxxxx, xxxxx domu a/nebo xxxxx xxxxxxxx schránky / Xxxxxx, house xxxxxx xxx/xx PO xxx |
2460 | XXX / Xxxxxx code | 2470 | Obec / Xxxx |
2480 | Xxx xxxxx / Xxxxxxx3) | 2490 | Xxxx / Xxxxxx xxxx4) |
2500 | Xxxxxxx / Xxxxxxxxx number | 2510 | Xxx / Xxx xxxxxx |
2520 | X-Xxxx | ||
2530 | Xxxxx xxxxxxx / Date xx xxxxxx6) | ||
2540 | Xxxxxxxxx příhoda / Xxxxxxxx Xxxxx xxxxxxxxx xxxxxxx / Xxxx of xxxxxxxx6) |
2550 | Xxxxx xxxxxxxxx xxxxxxx / Xxxxx xx xxxxxxxx |
2560 | Xxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxxx xx incident9) |
2570 | Xxxxxxxx nežádoucí xxxxxxx (xxxx. xxxxx, xxxxxxxxx xxxxxx ...) Xxxxxxx xx xxx incident (x.x. death, xxxxxxxxxxxxx xx health ...) |
2580 | Xxxxxxxxx xxxxxxxxx výrobce / Xxxxxxxxxxxx´x prliminary xxxxxxx 9) |
2590 | Předpokládané xxxxx xxx xxxxxxxxx hlášení xxxxxxxxx xxxxxxx / Xxxxxxxx xxxx of xxx incident follow-up xxxxxx6) |
2600 | Xxxxxxxxx nápravné xxxxxxxx, xxxxxxxx xxxx přijato9) Xxxxxxx corrective xxxxxx (xx xxx) |
2610 | Xxxxxx xxxxxx xxxxxxxxxx xxxxxxxx / Xxxxxxx xxxxxxxx |
2620 | Xxxxx x zdravotnickém xxxxxxxxxx xxxxxxxxx / xxxxxxxxxxxxxx x Xxxxx xxxxxxxxx Xxxxxxxxxxx xx medical xxxxxxx xxxx / xxxxxxxxxxx xx the Xxxxx Xxxxxxxx Xxxxxxxxx zdravotnický xxxxxxxxxx Custom-made xxxxxx xxx/xxx xx/xx |
2630 | Xxxx xxxxxxx xxxx xxxxxxxx zdravotnického xxxxxxxxxx Xxxx xx x xxxxxx xx x xxxxxxxxx xxxx xxx/xxx xx/xx |
2640 | Zdravotnický xxxxxxxxxx s měřící xxxxxx Xxxxxxx device xxxx xxxxxxxxx xxxxxxxx ano/yes xx/xx |
2650 | Xxxxxxxxxxxx xxxxxxxxxx, xx xxxxx xx xxxxxxxx i xxxxx týkající se xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxx a xxxxxxxxxxxx xxxxxx x xxxxxx xxxxxxxx, kterými xx xxxxxxx11) xxx/xxx xx/xx Xxxxxxx xxxxxx xxxxxxxxx xx xxx Xxx xx Peacefull Xxxxxxxxxxx xx Xxxxxxx Xxxxxx |
2660 | Xxxxxxx udělená Xxxxxxxxxxxxx zdravotnictví xxxxx xxxxxx o xxxxxxxxxxxxxx xxxxxxxxxxxx12) xxx/xxx ne/no Xxxxxxx xxxxxxxx xx Xxxxxxxx xx xxxxxx xxxxxxxxx to Xxxxxxx Xxxxxxx Xxx |
2670 | Xxxxxxxxx o xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxxxxxxx xxxxxxxx xxx/xxx xx/xx |
2680 | Xxxxxxxxxxxx prostředek xxxxxx na xxx / Medical device xxxxxx on xxx xxxxxx10) xxxxx xxxxxx x xxxxxxxxxxx xxxxxxxxxxx xx xxxxx xxxxxx x xxxxxxxxxxxxxx xxxxxxxxxxxx12) xxxxxxx13) xxxxxxxxx xx the Xxx xx Xxxxxxxxx Xxxxxxx xxxxxxxxx xx Xxxxxxx Devices Xxx xx Xxxxxxxx |
2690 | Xxxxx úřady byly xxxxxxxxxxx? Xxxxx other Xxxxxxxxxxx xxxx xxxxxxxx? |
Xxxxxxxx/Xxxx:
Xxxxxxxxxx xxxxxx xxxxxxx xxxxxxxxxxxxx xxxxxxxxxx xxx xxxxx výrobce xxxx xxxx xxxxxxxxxxxxxx xxxxxxxx ani xxxxxxxxxxx xxxxx x xxxxxxxx x xxxxxxxxx, xxx x xxx, xx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxx xxxx xxxxxxxx xxxx xxxxxxx k xxxxxxxx stavu xxxxxxxx xxxxx.
Submission xx xxxx xxxxxx xxxx xxx, in xxxxxx, xxxxxxxxx x conclusion xx the xxxxxxxxxxxx xxx/xx xxxxxxxxxx representative xx xxx xxxxxxxxx xxxxxxxxx xxxx the xxxxxxx of xxxx xxxxxx is xxxxxxxx xx accurate, xxxx xxx device(s) xxxxxx xxxxxx xx xxx xxxxxx and/or xxxx xxx xxxxxxx device(s) xxxxxx or contributed xx xxx xxxxxxx xxxxx or xxxxxxxxxxxxx xx xxx xxxxxx xx xxx person.
Xxxxxx prohlašuji, že xxxxxxx informace jsou xxxxxxx x xxxxxxxx.
X affirm that xxx xxxxxxxxxxx xxxxx xxxxx is xxxxxxx xx xxx best xx xx xxxxxxxxx.
Xxxx ........................................... Datum ...................................
Xxxx Xxxx
Jméno, xxxxxxxx ........................... Xxxxxx ........................
Xxxx, surname Xxxxxxxxx
Xxxxxxxx x xxxx xxxxxxx:/Xxxxx xxx other xxxxxxxxxxx:9)
2700 | Xxxxxxxx xxxxxxxx / Xxxxxxxxxx xxxxx xxxxxx příslušný xxxx – XXXX / To xx xxxxxx in xxxx xx xxx xxxxxxxxx xxxxxxxxx Xxxxx doručení xxxxxxxxxxx xxxxx / Xxxx of xxxxxxxx xx competent xxxxxxxxx6) | ||
2710 | Zodpovědný xxxxxxxxx / Xxxxxx xxxxxxxxxxx | 2920 | Xxxxxxx/Xxxxxxxxx xxxxxx |
2730 | Xxxxx xxxxxxx Xxxxxx xxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxxxxx/ Xxxx xx xxxxxxxx xx xxxxxxxxx xx Health Xxxxxxxxxxx xxx Xxxxxxxxxx6) | ||
Xxxxxx x xxxxxxxxxx xxxxxxxxx
Xxxxx xx xxxxxxxxxx xxxx:
1) Xxxxxx xx x xxxxxxxxxxxx xxxx xxxxx (norma ISO 3166), xxxxxxx x (XXX) xxxxxxxxxxxxxxx xxxxx xxxxxxxx.
1) Xxxx xxxx xx always xxxxxxxx of xxx xxx-xxxxxxx country xxxx xx xxxxxxxx XXX 3166 xxxxxxxx xx x xxxxx xxx xxx xxxxxxxx-xxxxxx xx xxx xxxxxxx.
2) Xxxxxx výrobce xxxx xxxxxxxxxxxx xxxxxxxx. Xxxxxxxx xx ode dne xxxxxxxxx xxxxxxx x xxxxxxxxxxx Xxxxx xxxxxxxxx xx Xxxxxxxx unie, xxxxx zdravotnický xxxxxxxxxx xxxxxxx nežádoucí příhodou xx xxxxx x xxxxxxxx x xxxxxxxxx xxxxx Xxxxxxxxxx xxxxxxxxxxxx.
2) Xx xx xxxxxx xx xx x xxxxxxxxxxxx xx xx xx authorized xxxxxxxxxxxxxx. To xx xxxxxx xx from xxx day xxxx x contract concerning xxx xxxxxxxx of xxx Czech Xxxxxxxx xxxx xxx European Xxxxx is xxxxx, xxxxxxxxx xxxx a xxxxxxx device xxxxxx xxxx in an xxxxxxxx originated in xxxx xx xxx xxxxxx states xx xxx Xxxxxxxx Union.
3) Xxxxxxxx xxxx xxx země x xxxxxxx x xxxxxx XXX 3166: 1993, xxxxxxxxx:
3) Xxxxxx xxx xxx xxxxx xxx xxx xxxxxxxxx xxxxxxxxx (acc. xx xxxxxxxx ISO 3166: 1993), x.x.:
XX ... Xxxxxxxx / Austria XX ... Xxxxx / Xxxxxxx
XX ... Xxxxxx / Belgium XX ... Xxxxxx / Xxxxxxx
DE ... Xxxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxx
XX ... Xxxxxx / Xxxxxxx XX ... Lichtenštejnsko / Xxxxxxxxxxxxx
ES ... Xxxxxxxxx / Xxxxx XX ... Xxxxxxxxxxx / Xxxxxxxxxx
XX ... Xxxxxx / Xxxxxxx NL ... Xxxxxxxxxx / Xxxxxxxxxxx
XX ... Xxxxxxx / Xxxxxx XX ... Xxxxxx / Xxxxxx
GB ... Xxxxx Xxxxxxxx / Xxxxxx Xxxxxxx PT ... Xxxxxxxxxxx / Portugal
XX ... Xxxxx / Greece XX ... Xxxxxxx / Xxxxxx
4) Xxxxxxxx xxxx xxxxx xxxxx Xxxxxxxx ČSÚ xx xxx 27.4.1999, částka 33/1999 Xx., v xxxxxxx xxxxx.
4) Xxxxxx xxx the xxxxxx xxxxx xxxxxxxxxx xx XXX Xxxxxxxxxxx xxxx 27.4.1999, xxxx 33/1999 Xxxx. xx xxxxxxx.
5) Vyplňte xxxxx x xxxxxxxx x xxxxxxx osoby, xxxxx xxxx xxxxxxxx xxxxx, jde-li x xxxxxxxxxx xxxxx.
5) Xxxxxx xxxxx a xxxxx name xxx x xxxxxxx xx xxxx of a xxxxxxxx xxxxxx, xxx xx xxxx xx x xxxxx xxxxxx xxx xxxx or x name xx x xxxxxxxxxx company.
6) Rok, xxxxx, xxx
6) Xxxx, xxxxx, xxx
7) Xxxxxxx xxxxxxx xxxx x xxxxx skupiny xxxxxxxxxxxxxx xxxxxxxxxx xxxxx Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxx (XXXXX) xxxx podle Xxxxxxxx xxxxxxxxxxxx zdravotnických xxxxxxxxxx (XXXX), až xxxx k dispozici (xxxx. 10966; xxxxxx, xxx).
7) Xxxxxx xxxxx xxx relevant xxxx xxx its xxxxxxxxxxx from xxx xxxxxxxxxxxx Universal Xxxxxxx Xxxxxx Xxxxxxxxxxxx System (XXXXX) xx Xxxxxx Xxxxxxx Xxxxxxx Nomenclature (XXXX), xxxx xxxxx xx available (x.x. 10966; Xxxxxxxxxx, Xxxxx).
8) Xxxx x xxxxx xxxxxxxxx xxxx xxxxxxxx na ČSN XX ISO 15225: 2000. Xxxxxxx xx xxxxxxxx xxxxx xxxxx xxxxxx kategorie, xx xxxxx xxxxx x xxxxxx od xxxxxxx x xx xxxxxxx X.
8) Xxxxxx xxxxxxxx code xxx xxxx xxx xxxxx xx XXX XX XXX 15225: 2000. Xxx xxxxxx xxxxx xx assigned xx xxx xxxxx category xx which it xxxx, xxxxxx from x to X.
Xxx xxx. | Xxxxx xxxxxxxxx xxxxx. xxxxxxxxxx | X | Code xx xxx. | Xxxx of xxxxxxxx of xxxxxxx xxxxxxx | R |
06 | Xxxxxxxxxxxx xxxxxxxxxxxx prostředky xx xxxxx Xx xxxxx xxxxxxxxxx devices | x | 02 | Anestetické x respirační xxxxxxxxxxxx xxxxxxxxxx Xxxxxxxxxxx / xxxxxxxxxxx devices | x |
01 | Xxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxxxxxx xxxxxxx | x | 04 | Xxxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Electro xxxxxxxxxx xxxxxxx xxxxxxx | x |
07 | Xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxxx xxxxxxxxxx Xxx-xxxxxx xxxxxxxxxxx devices | c | 09 | Xxxxxxxxxxxx xxxxxxxxxx – xxxxxxxx xxx xxxxxxxxx použití Xxxxxxxx xxxxxxxxxxx | x |
03 | Xxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxx | d | 10 | Zdravotnické xxxxxxxxxx xxx xxxxxxxxxxx použití Xxxxxx xxx devices | x |
08 | Oftalmologické x optické xxxxxxxxxxxx xxxxxxxxxx Xxxxxxxxx and xxxxxxx devices | e | 11 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx xxxxx Xxxxxxxxx xxxx for xxxxxxxx xxxxxxx | x |
12 | Xxxxxxxxxxxx prostředky xxx xxxxxxxxxxx a xxxxxxx xxxxxxx Diagnostic xxx therapeutic radiation | x | 05 | Xxxxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx Xxxxxxxx xxxxxxxx | x |
9) X xxxxxxx xxxxxxx použijte xxxxx xxxx papíru.
9) Xxx xxxxxxxxxx sheet xx xxxxxxxxx.
10) Xxxxxxx xxxxx v xxxxxxx, xx zprávu xxxxxx XXXXx xxxxxxx xxxx xxxxxxxxxxxx xxxxxxxx.
10) To xx xxxxxx xx only xx xxxxxxxxxxxx / xxxxxxxxxx xxxxxxxxxxxxxx xx xxxxxxxxx xx SÚKL.
11) V České xxxxxxxxx xxxxx x. 18/1997 Sb., o xxxxxxx využívání xxxxxxx xxxxxxx x ionizujícího xxxxxx (xxxxxxx xxxxx) x x xxxxx x xxxxxxxx některých xxxxxx, xx xxxxx xxxxxxxxxx předpisů.
11) Xx Xxxxx Xxxxxxxx Xxx No. 18/1997 Xxxx., on Xxxxxxxxx Xxxxxxxxxxx of Xxxxxxx Xxxxxx and xxxxxxxx Xxxxxxxxx (Atomic Act) xxx xxxxxxxxxx and xxxxxxx xxxx Xxxx xx xxxxxxx.
12) X Xxxxx xxxxxxxxx xxxxx x. 123/2000 Xx., o zdravotnických xxxxxxxxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx xxxxx xxxxxx č. 130/2003 Xx.
12) Xx Xxxxx Republic Xxx Xx. 123/2000 Xxxx., xx Xxxxxxx Xxxxxxx xxx amendments to xxxx xxxxxxx Acts xx amended Xxx Xx. 130/2003 Coll.
13) X Xxxxx xxxxxxxxx zákon č. 22/1997 Xx., x xxxxxxxxxxx xxxxxxxxxxx xx xxxxxxx a o xxxxx x xxxxxxxx xxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx předpisů.
13) Xx Czech Xxxxxxxx Act Xx. 22/1997 Xxxx., xx Xxxxxxxxx Xxxxxxx xx Xxxxxxxx xxx xxxxxxxxxx xxx xxxxxxxx xxxx Xxxx as xxxxxxx.
Xxxxxxx x. 2 k vyhlášce x. 501/2000 Xx.
Xxxxxxxx XX
xxx xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx zdravotnického prostředku
Xxxxxxxx Xxxxx Xxxxxx Xxxx
3100 | Xxxxxxxxx xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxx detexting xxxxxxx xxxxxxxx Kód příslušného xxxxx / Code xx competent xxxxxxxxx XX/XX02 | ||
3110 | Název xxxxxxxxxxx xxxxx / Xxxx of xxxxxxxxx xxxxxxxxx Státní xxxxx xxx xxxxxxxx xxxxx (xxxx xxx „XXXX“) | ||
3120 | Xxxxx, xxxxx xxxx a/nebo xxxxxxxx xxxxxxxx / Xxxxxx, xxxxx number xxx/xx XX box Xxxxxxxxx 48 | ||
3130 | XXX / Xxxxxx xxxx 100 41 | 3140 | Xxxx / City Xxxxx 10 |
3150 | Xxxxxxx / Xxxxxxxxx xxxxxx 272&xxxx;185&xxxx;780, 272&xxxx;185&xxxx;705 | 3160 | Xxx / Xxx xxxxxx 272&xxxx;185&xxxx;764 |
3170 | X-Xxxx xxxx@xxxx.xx | 3180 | Xxxx / Xxxxxxx XX |
3190 | Hlášení xxx XXXX xx xxxxxxxx, xxxxx xxxxx xxxxxxxxx příhodu / Xxxxxx xx SÚKL xx xxxxxxx submitting xxxxxxx xxxxxxxx Xxxxx xxxxxxxx, xxxxx xxxxxx xxxxxx / Xxxx xx xxxxxxx submitting xxxxxx | ||
3195 | Xxx xxxxxxx / Xxxx xx subject1) | ||
3200 | Výrobce / Manufacturer Xxxxxxxx / User Xxxxxxxxxxxx xxxxxxxx / Xxxxxxxxxx representative2) Xxxxxxx / Other Xxxxxxx / Xxxxxxxx | ||
3210 | Xxxxx, číslo xxxx x/xxxx xxxxxxxx xxxxxxxx / Street, xxxxx xxxxxx xxx/xx XX xxx | ||
3220 | XXX / Xxxxxx xxxx | 3230 | Xxxx / Xxxx |
3240 | Xxx xxxxx / Xxxxxxx code 2) | 3250 | Xxx kraje / Xxxxxx xxxx3) |
3260 | Xxxxx xxxxxxxxx xxxxx / Xxxx of xxxxxxx xxxxxx4) | ||
3270 | Telefon / Xxxxxxxxx xxxxxx | 3280 | Xxx / Xxx xxxxxx |
3290 | X-Xxxx | ||
3300 | Xxxxx xxxxxxx / Xxxx xx xxxxxx5) | ||
3310 | Xxxxx xxxxxxxxx xxxxxxx (xxxxxxxxx XXXX) Xxxxxxxx xxxxxx (xxxxxxxxxx xxxxxx xxxxxxxx by XXXX) XX/XX02/..... |
3320 | Zdravotnický xxxxxxxxxx / Xxxxxxx xxxxxx Xxxxx zdravotnického xxxxxxxxxx / Commercial xxxx xx xxxxxxx xxxxxx |
3330 | Xxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx XXXXX / GMDN7) XXXX / XXXX code xx medical device |
3340 | Xxxxx xxxxxxx zdravotnického xxxxxxxxxx xxxxx podle UMDNS / XXXX (např. xxxxxxxxxxxxxxxxx, xxxxxx neivazivní)7) XXXXX / XXXX xxxxxxxxxxx xx medical xxxxxx xx Czech (x.x. Xxxxxxxxxx, Xxxxxxx, Xxxxxxxx Xxxxxxxxxxx) |
3345 | Kód kategorie xxxxxxxxxxxxxx prostředku8) Category xx xxxxxxx xxxxxx |
3350 | Modelové xxxx katatlogové xxxxx xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxx xx catalogue xxxxxx |
3360 | Xxxxx(x) xxxxx xxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxx(x) xx xxx xxxxxx(x) |
3370 | Xxxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xx xxxxxxxx8) Associated xxxxxxx xxxxxxx/xxxxxxxxxxx (if xxxxxxxxxx) |
3380 | Verze xxxxxxxxxxxx xxxxxxxx xxxxxxxx xx součástí8) Xxxxxxxx xxxxxxx (if xxxxxxxxxx) |
3390 | Výrobce / Xxxxxxxxxxxx Kód xxxxxxx / Xxxx xx xxxxxxxxxxxx1) |
3400 | Xxxxx xxxxxxx / Xxxx xx manufacturer4) |
3410 | Xxxxxxxxxxxxx číslo xxxxxxxxxxxx xxxxx, xxxxx shodu xxxxxxxxx. Identification number xx Xxxxxxxx Xxxx xxxxxxxx in xxxxxxxxxx xxxxxxxxxx. |
2410 | Xxxxxx xxxxx xxxxxxx xxx xxxxx xxxxxxxxx příhodu xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxx? Xxx the xxxxxxxxx xxxx previously reported xxxxxxxx xxxxxxxxx xxxx xxxxxxx device? xxx / xxx xx /xx |
2420 | Datum xxxxxxx xxxxxxxx nežádoucí xxxxxxx / Xxxx xx xxxxxx xx xxxxxxx incident5) |
2430 | Xxxxxxxx xxx, xxx do xxxxx xxxx (xx xxxx XX, kde xx xxxxxxxxxxxx prostředek prodává)9) Xx yes, to xxxxx xxxxxxx (xxxxx XXX xxxxxxxxx xxxxx xxx xxxxxxx device xx on sale) XX BE DE XX XX FI XX XX XX XX IS IT XX XX XX XX XX XX |
3450 | Xxxxxxx xxxxxxxxx xxxxxxx / xxxxxx Investigation / xxxxxxxxxxx Výsledek x xxxxx šetření xxxxxxxxxxx xxxxxxxx8) Xxxxxx xxx conclusion xx xxxxxxxxxxxx´x xxxxxxxxxxxxx |
3460 | Xxxxx xxxxxxx xxxxxxxxx xxxxxxx (jestliže xxxx provedeno)8) Xxxxxxx xxxxxxxxxxxxx (if xxx) |
3470 | Xxxxxxxxx xxxxxxxx xxxxxxxx (xxxxxxxx xxxx xxxxxxx)8) Xxxxxxx xxxxxxxxxx xxxxxx (xx xxx) |
3480 | Časový rozvrh xxxxxxxxxx xxxxxxxx / Xxxxxxx schedule of xxxxxxxxxx xxxxxx (xx xxx) |
Xxxxxxxx/Xxxx:
Xxxxxxxxxx tohoto xxxxxxx xxxxxxxxxxxxx xxxxxxxxxx ani xxxxx xxxxxxx xxxx xxxx zplnomocněného xxxxxxxx xxx xxxxxxxxxxx úřadu x úplnosti x xxxxxxxxx, xxx x xxx, xx xxxxxxxxxxxx xxxxxxxxxx jakkoli xxxxxx xxxx xxxxxxxx xxxx xxxxxxx k xxxxxxxx xxxxx xxxxxxxx xxxxx.
Xxxxxxxxxx xx this xxxxxx xxxx xxx, xx xxxxxx, represent x conclusion by xxx xxxxxxxxxxxx xxx/xx xxxxxxxxxx xxxxxxxxxxxxxx or xxx xxxxxxxxx authority xxxx xxx xxxxxxx xx this report xx complete xx xxxxxxxx, xxxx the xxxxxx(x) xxxxxx xxxxxx xx xxx manner xxx/xx xxxx xxx xxxxxxx xxxxxx(x) xxxxxx xx contributed xx xxx xxxxxxx xxxxx xx deterioration xx xxx health of xxx xxxxxx.
Čestně xxxxxxxxxx, xx xxxxxxx xxxxxxxxx jsou xxxxxxx x pravdivé.
X xxxxxx xxxx the xxxxxxxxxxx xxxxx xxxxx xx correst to xxx xxxx xx xx xxxxxxxxx.
Obec ........................................... Xxxxx ...................................
City Xxxx
Xxxxx, příjmení ........................... Xxxxxx ........................
Xxxx, xxxxxxx Xxxxxxxxx
Xxxxxxxx x xxxx xxxxxxx: / Xxxxx xxx xxxxx information:8)
3490 | Xxxxxxxx xxxxxxxx / Xxxxxxxxxx xxxxx Xxxxxx xxxxxxxxx xxxx / To be xxxxxx xx only xx the xxxxxxxxx xxxxxxxxx Xxxxx xxxxxxxx xxxxxxxxxxx xxxxx / Xxxx xx xxxxxxxx xx competent authority5) | ||
3500 | Zodpovědný xxxxxxxxx / Xxxxxx xxxxxxxxxxx | 3510 | Xxxxxxx/Xxxxxxxxx number |
3520 | Xxxxx xxxxxxx Xxxxxx xxxxxxxxxxxxxx xxxxxxxxx a xxxxxxxxxxx5) | ||
Xxxxxx x xxxxxxxxxx xxxxxxxxx
Xxxxx xx xxxxxxxxxx xxxx:
1) Xxxxxx xx x xxxxxxxxxxxx xxxx xxxxx (xxxxx XXX 3166), xxxxxxx x (XXX) xxxxxxxxxxxxxxx xxxxx xxxxxxxx.
1) This xxxx xx always xxxxxxxx xx the xxx-xxxxxxx country code xx xxxxxxxx XXX 3166 xxxxxxxx by x xxxxx and xxx xxxxxxxx-xxxxxx xx xxx subject.
2) Xxxxxxxx xxxx pro xxxx v souladu x xxxxxx XXX 3166: 1993, xxxxxxxxx:
2) Xxxxxx xxx xxx xxxxx for xxx xxxxxxxxx xxxxxxxxx (xxx. xx xxxxxxxx XXX 3166: 1993), x.x.:
AT ... Xxxxxxxx / Xxxxxxx XX ... Xxxxx / Ireland
XX ... Xxxxxx / Xxxxxxx XX ... Island / Xxxxxxx
XX ... Německo / Xxxxxxx IT ... Xxxxxx / Italy
XX ... Xxxxxx / Xxxxxxx XX ... Xxxxxxxxxxxxxxx / Liechtenstein
XX ... Xxxxxxxxx / Spain XX ... Xxxxxxxxxxx / Xxxxxxxxxx
XX ... Xxxxxx / Finland XX ... Xxxxxxxxxx / Xxxxxxxxxxx
XX ... Xxxxxxx / Xxxxxx XX ... Xxxxxx / Xxxxxx
XX ... Xxxxx Xxxxxxxx / Xxxxxx Kingdom XX ... Xxxxxxxxxxx / Xxxxxxxx
XX ... Xxxxx / Xxxxxx XX ... Xxxxxxx / Sweden
3) Xxxxxxxx xxxx krajů xxxxx Xxxxxxxx XXX xx xxx 27.4.1999, xxxxxx 33/1999 Xx., x xxxxxxx znění.
3) Please use xxx xxxxxx xxxxx xxxxxxxxxx by CSO Xxxxxxxxxxx from 27.4.1999, xxxx 33/1999 Coll. xx amended.
4) Xxxxxxx jméno x xxxxxxxx x xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxxxx, xxx-xx x xxxxxxxxxx xxxxx.
4) Xxxxxx xxxxx x first xxxx xxx x xxxxxxx xx xxxx xx x xxxxxxxx xxxxxx, xxx in xxxx xx x xxxxx xxxxxx xxx xxxx xx x name xx a commercial xxxxxxx.
5) Xxx, xxxxx, den
5) Xxxx, xxxxx, xxx
6) Vyplňte správné xxxx a název xxxxxxx zdravotnických prostředků xxxxx Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxx (XXXXX) xxxx xxxxx Xxxxxxxx nomenklatury xxxxxxxxxxxxxx prostředků (GMDN), xx xxxx k xxxxxxxxx (xxxx. 10966; xxxxxx, mul).
6) Xxxxxx enter the xxxxxxxx code xxx xxx xxxxxxxxxxx xxxx xxx nomenclature Xxxxxxxxx Xxxxxxx Device Xxxxxxxxxxxx Xxxxxx (XXXXX) xx Xxxxxx Medical Xxxxxxx Xxxxxxxxxxxx (GMDN), xxxx xxxxx is available (x.x. 10966; Compresses, Xxxxx).
7) Xxxx x xxxxx xxxxxxxxx xxxx xxxxxxxx xx XXX XX XXX 15225: 2000. Xxxxxxx xx označuje xxxxx xxxxx xxxxxx xxxxxxxxx, xx xxxxx xxxxx x xxxxxx od xxxxxxx x xx xxxxxxx X.
7) Xxxxxx category xxxx xxx xxxx xxx xxxxx on XXX XX XXX 15225: 2000. Xxx xxxxxx xxxxx be assigned xx the xxxxx xxxxxxxx in xxxxx xx fits, xxxxxx xxxx x xx X.
Xxx xxx. | Xxxxx xxxxxxxxx xxxxx. xxxxxxxxxx | X | Xxxx xx xxx. | Xxxx xx category of xxxxxxx devices | R |
06 | Xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xx xxxxx Xx xxxxx xxxxxxxxxx xxxxxxx | x | 02 | Xxxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxxxxxxx / xxxxxxxxxxx xxxxxxx | x |
01 | Xxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxx implantable xxxxxxx | x | 04 | Xxxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxxx xxxxxxx | x |
07 | Xxxxxxxxx xxxxxxxxxxxxx zdravnotnické xxxxxxxxxx Xxx-xxxxxx implantable xxxxxxx | x | 09 | Xxxxxxxxxxxx xxxxxxxxxx – nástroje xxx opakované xxxxxxx Xxxxxxxx instruments | x |
03 | Xxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxx | x | 10 | Zdravotnické xxxxxxxxxx xxx jednorázové xxxxxxx Xxxxxx use xxxxxxx | x |
08 | Xxxxxxxxxxxxxx x xxxxxxx xxxxxxxxxxxx xxxxxxxxxx Ophthamic xxx xxxxxxx devices | x | 11 | Xxxxxxxxxxxx xxxxxxxxxx xxx postižené xxxxx Technical xxxx xxx xxxxxxxx xxxxxxx | x |
12 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx x terapii zářením Xxxxxxxxxx and xxxxxxxxxxx xxxxxxxxx | x | 05 | Xxxxxxxxxxxx prostředky x xxxxxxxxxxx xxxxxxxx Xxxxxxxx hardware | x |
8) X xxxxxxx xxxxxxx xxxxxxxx xxxxx xxxx xxxxxx.
8) Xxx additional xxxxx xx xxxxxxxxx.
9) Xxxxxx výrobce xxxx xxxxxxxxxxxx zástupce. Xxxxxxxx xx xxx xxx platnosti xxxxxxx x xxxxxxxxxxx Xxxxx xxxxxxxxx xx Xxxxxxxx xxxx, xxxxx zdravotnický xxxxxxxxxx dotčený xxxxxxxxx xxxxxxxx xx xxxxx x xxxxxxxx x xxxxxxxxx xxxxx Evropských xxxxxxxxxxxx.
9) Xx xx filled in xx a xxxxxxxxxxxx xx by xx xxxxxxxxxx xxxxxxxxxxxxxx. Xx xx xxxxxx in xxxx xxx the xxx xxxx x xxxxxxxx concerning xxx xxxxxxxx xx the Xxxxx Xxxxxxxx into xxx Xxxxxxxx Xxxxx xx xxxxx, xxxxxxxx xxxx a xxxxxxx xxxxxx xxxxxx xxxx xx an incident xxxxxxxxxx in xxxx xx xxx xxxxxx xxxxxx xx the Xxxxxxxx Xxxxx.".
Čl. XX
Xxxx xxxxxxxx nabývá xxxxxxxxx xxxx 1. xxxxx 2003.
Xxxxxxxxxx:
MUDr. Xxxxxxxx x. x.
Xxxxxxxxx
Xxxxxx předpis č. 304/2003 Xx. xxxxx xxxxxxxxx xxxx 1.10.2003.
Xxxxxx xxxxxxx x. 304/2003 Xx. byl xxxxxx xxxxxxx xxxxxxxxx č. 268/2014 Sb. x xxxxxxxxx xx 1.4.2015.
Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx aktualizováno, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx právního předpisu.