Právní předpis byl sestaven k datu 30.03.2015.
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 dne 3. xxxx 2003,
xxxxxx xx mění xxxxxxxx x. 501/2000 Xx., xxxxxx xx stanoví xxxxx, xxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxxxxx xxxxxxxxxx, jejich evidování, xxxxxxx a vyhodnocování, xxxxxxxxxxx x její xxxxxxxxxx x následné xxxxxxxxx s xxxxx xxxxxxxxxxx vzniku xxxxxxxxxxx xxxxxx, zejména jejich xxxxxxxxx (xxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx)
Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxxxx xxxxx §34 xxxxxx x. 123/2000 Xx., x xxxxxxxxxxxxxx xxxxxxxxxxxx a x změně xxxxxxxxxxxxx xxxxxx:
Xx. X
Xxxxxxx x. 1 x 2 x xxxxxxxx č. 501/2000 Sb., xxxxxx xx stanoví xxxxx, xxxxxxx ohlašování xxxxxxxxxxx xxxxxx xxxxxxxxxxxxxx prostředků, xxxxxx xxxxxxxxx, xxxxxxx x xxxxxxxxxxxxx, dokumentace x xxxx xxxxxxxxxx x xxxxxxxx xxxxxxxxx x xxxxx předcházení xxxxxx xxxxxxxxxxx xxxxxx, xxxxxxx jejich xxxxxxxxx (xxxxxxxx o xxxxxxxxxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx), xxxxx:
"Xxxxxxx x. 1 x xxxxxxxx x. 501/2000 Xx.
Xxxxxxxx I
xxx xxxxx xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx prostředku
Xxxxxxxx Xxxxxxxx Xxxxxx Xxxx
Xxxxxx k xxxxxxx xxxxxxxxx příhody
Xxxxx xx reporting xxxxxxxx
Xxxxxxx xxxx xxx xxxxxx xxxxxxxxxx, x když xxxxxx x dispozici xxxxxxx xxxxxxxx xxxxxxxxx.
Xxx xxxxxx xxxxxx be xxxx as soon xx possible xxxx xx xxx xxx xxx information necessary xxx the completion xx the xxxx xx xxxxxxxxx.
2100 | Xxxxxxxxx úřad provádějící xxxxxxx nežádoucí příhody / Xxxxxxxxxx detexting xxxxxxx xxxxxxxx Kód xxxxxxxxxxx xxxxx / Xxxx xx competent xxxxxxxxx XX/XX02 | ||
2110 | Xxxxx xxxxxxxxxxx xxxxx / Name of xxxxxxxxx xxxxxxxxx Xxxxxx xxxxx xxx xxxxxxxx xxxxx (xxxx jen „XXXX“) | ||
2120 | Xxxxx, xxxxx donu x/xxxx xxxxxxxx xxxxxxxx / Xxxxxx, house xxxxxx xxx/xx PO box Xxxxxxxxx 48 | ||
2130 | XXX / Xxxxxx xxxx 100 41 | 2140 | Xxxx / Xxxx Xxxxx 10 |
2150 | Xxxxxxx / Xxxxxxxxx xxxxxx 272&xxxx;185&xxxx;780, 272&xxxx;185&xxxx;705 | 2160 | Fax / Xxx xxxxxx 272&xxxx;185&xxxx;764 |
2170 | X-Xxxx xxxx@xxxx.xx | 2180 | Stát / Xxxxxxx XX |
2190 | Xxxxxxx xxx XXXX xx subjektu, xxxxx xxxxx nežádoucí xxxxxxx / Xxxxxx xx XXXX of subject xxxxxxxxxx xxxxxxx xxxxxxxx Xxxxx subjektu, který xxxxxx xxxxxx / Xxxx xx subject xxxxxxxxxx xxxxxx | ||
2195 | Xxx xxxxxxxx / Xxxx of xxxxxxx1) | ||
2200 | Xxxxxxx / Xxxxxxxxxxxx Xxxxxxxx / User Zplnomocněný xxxxxxxx / Xxxxxxxxxx xxxxxxxxxxxxxx2) Xxxxxxx / Xxxxx Xxxxxxx / Importer | ||
2210 | Xxxxx, číslo xxxx x/xxxx xxxxxxxx xxxxxxxx / Street, xxxxx xxxxxx and/or XX xxx | ||
2220 | XXX / Xxxxxx code | 2230 | Xxxx / Xxxx |
2240 | Xxx xxxxx / Xxxxxxx xxxx3) | 2250 | Xxx xxxxx / Xxxxxx xxxx4) |
2260 | Xxxxx xxxxxxxxx osoby / Xxxx of xxxxxxx xxxxxx5) | ||
2270 | Telefon / Xxxxxxxxx xxxxxx | 2280 | Xxx / Xxx number |
2290 | X-Xxxx | 2230 | Xxxxx xxxxxxx / Xxxx xx xxxxxx6) |
2305 | Xxxxx xxxxxxxxx příhody (xxxxxxxxx XXXX) Xxxxxxxx xxxxxx (xxxxxxxxxx number xxxxxxxx xx XXXX) XX/XX02/..... | ||
2310 | Xxxxxxxxxxxx xxxxxxxxxx / Xxxxxxx xxxxxx Xxxxx xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxxxxxxx xxxx of xxxxxxx xxxxxx |
2320 | Xxx skupiny xxxxxxxxxxxxxx xxxxxxxxxx xxxxx XXXXX / XXXX7) XXXX / XXXX xxxx xx xxxxxxx xxxxxx |
2330 | Název xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx xxxxx UMDNS / XXXX (xxxx. kardiostimulátory, xxxxxx xxxxxxxxxx)7) XXXXX / XXXX designation xx xxxxxxx xxxxxx xx Xxxxx (e.g. Xxxxxxxxxx, Cardiac, Xxxxxxxx Xxxxxxxxxxx) |
2335 | Kód xxxxxxxxx zdravotnického xxxxxxxxxx8) Xxxxxxxx of xxxxxxx xxxxxx |
2340 | Xxxxxxxx xxxx xxxxxxxxxxx číslo xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxx xx xxxxxxxxx xxxxxx |
2350 | Xxxxx(x) xxxxx xxxx šarže xxxxxxxxxxxxxx xxxxxxxxxx Serial xxxxxx(x) xx lot xxxxxx(x) |
2360 | Doprovodné xxxxxxxxxxxx xxxxxxxxxx / xxxxxxxxxxxxx (xxxxxxxx je xxxxxxxx)9) Xxxxxxxxxx xxxxxxx xxxxxxx / xxxxxxxxxxx (if xxxxxxxxxx) |
2370 | Verze xxxxxxxxxxxx xxxxxxxx (xxxxxxxx xx xxxxxxxx)9) Software xxxxxxx (xx xxxxxxxxxx) |
2380 | Xxxxxxx / Xxxxxxxxxxxx Xxx xxxxxxx / Xxxx xx xxxxxxxxxxxx1) |
2390 | Xxxxx xxxxxxx / Xxxx of xxxxxxxxxxxx5) |
2400 | Identifikační xxxxx autorizované xxxxx, xxxxx shodu posoudila. Xxxxxxxxxxxxxx xxxxxx xx Xxxxxxxx Xxxx xxxxxxxx xx conformity xxxxxxxxxx. XX/XX...... |
2410 | Hlásil xxxxx xxxxxxx xxx xxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx typu? Xxx the reporting xxxx xxxxxxxxxx xxxxxxxx xxxxxxxx involving xxxx xxxxxxx device? xxx / xxx xx / xx |
2420 | Datum xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx / Xxxx xx xxxxxx xx xxxxxxx incident6) |
2430 | Xxxxxxxx xxx, xxx xx xxxxx xxxx (xx xxxx XX, kde xx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx)2) Xx xxx, to xxxxx country (xxxxx XXX countries where xxx xxxxxxx xxxxxx xx xx xxxx) XX XX XX XX ES FI XX GB XX XX IS XX XX XX XX XX XX SE |
2440 | Xxxxxxx xxxxxxx / Xxxxxx xx xxxxxxxxxxxx Xxxxxxx výrobci xxxxxx (xxxxxxxx, kontaktní osoba, xxxx xxxxx):10) Report xx xxxxxxxxxxxx xx (xxxx, xxxxxxx xxxxxx xx xxxxx xxxxxx): |
2450 | Xxxxx, xxxxx xxxx x/xxxx xxxxx poštovní xxxxxxxx / Street, house xxxxxx xxx/xx PO xxx |
2460 | XXX / Xxxxxx xxxx | 2470 | Obec / Xxxx |
2480 | Xxx xxxxx / Xxxxxxx3) | 2490 | Xxxx / Region xxxx4) |
2500 | Xxxxxxx / Xxxxxxxxx number | 2510 | Xxx / Fax xxxxxx |
2520 | X-Xxxx | ||
2530 | Datum xxxxxxx / Date of xxxxxx6) | ||
2540 | Xxxxxxxxx xxxxxxx / Xxxxxxxx Xxxxx xxxxxxxxx xxxxxxx / Xxxx xx xxxxxxxx6) |
2550 | Xxxxx xxxxxxxxx xxxxxxx / Xxxxx of xxxxxxxx |
2560 | Xxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxxx xx xxxxxxxx9) |
2570 | Xxxxxxxx xxxxxxxxx příhody (xxxx. úmrtí, xxxxxxxxx xxxxxx ...) Xxxxxxx xx xxx xxxxxxxx (x.x. death, xxxxxxxxxxxxx xx health ...) |
2580 | Předběžné xxxxxxxxx xxxxxxx / Xxxxxxxxxxxx´x prliminary comment 9) |
2590 | Xxxxxxxxxxxxx xxxxx xxx xxxxxxxxx hlášení xxxxxxxxx příhody / Xxxxxxxx date of xxx xxxxxxxx xxxxxx-xx xxxxxx6) |
2600 | Xxxxxxxxx xxxxxxxx xxxxxxxx, xxxxxxxx xxxx xxxxxxx9) Xxxxxxx xxxxxxxxxx xxxxxx (xx any) |
2610 | Xxxxxx xxxxxx xxxxxxxxxx opatření / Xxxxxxx schedule |
2620 | Xxxxx x xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxxx / xxxxxxxxxxxxxx x Xxxxx xxxxxxxxx Xxxxxxxxxxx xx xxxxxxx devices xxxx / distributed xx the Xxxxx Xxxxxxxx Zakázkový xxxxxxxxxxxx xxxxxxxxxx Xxxxxx-xxxx device ano/yes ne/no |
2630 | Xxxx systému xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx Xxxx of x xxxxxx xx x xxxxxxxxx pack xxx/xxx xx/xx |
2640 | Xxxxxxxxxxxx xxxxxxxxxx x xxxxxx xxxxxx Xxxxxxx xxxxxx xxxx xxxxxxxxx xxxxxxxx ano/yes xx/xx |
2650 | Xxxxxxxxxxxx xxxxxxxxxx, xx xxxxx xx vztahuje x xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxx x ionizujícího xxxxxx x xxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx11) xxx/xxx xx/xx Xxxxxxx xxxxxx xxxxxxxxx xx the Xxx xx Xxxxxxxxx Xxxxxxxxxxx xx Nuclear Energy |
2660 | Výjimka xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxxxxx podle xxxxxx x xxxxxxxxxxxxxx xxxxxxxxxxxx12) ano/yes xx/xx Xxxxxxx xxxxxxxx by Xxxxxxxx xx xxxxxx xxxxxxxxx xx Medical Xxxxxxx Act |
2670 | Xxxxxxxxx x xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxxxxxxx xxxxxxxx ano/yes xx/xx |
2680 | Xxxxxxxxxxxx xxxxxxxxxx xxxxxx xx xxx / Xxxxxxx device xxxxxx xx xxx xxxxxx10) xxxxx xxxxxx x technických xxxxxxxxxxx xx xxxxx xxxxxx o xxxxxxxxxxxxxx xxxxxxxxxxxx12) xxxxxxx13) xxxxxxxxx xx the Xxx of Xxxxxxxxx Xxxxxxx xxxxxxxxx xx Xxxxxxx Xxxxxxx Xxx xx Products |
2690 | Xxxxx xxxxx xxxx xxxxxxxxxxx? Xxxxx xxxxx Xxxxxxxxxxx were xxxxxxxx? |
Xxxxxxxx/Xxxx:
Xxxxxxxxxx xxxxxx xxxxxxx nepředstavuje xxxxxxxxxx xxx xxxxx xxxxxxx xxxx xxxx xxxxxxxxxxxxxx xxxxxxxx xxx xxxxxxxxxxx xxxxx x xxxxxxxx x přesnosti, xxx x tom, že xxxxxxxxxxxx prostředek jakkoli xxxxxx nebo xxxxxxxx xxxx xxxxxxx k xxxxxxxx xxxxx xxxxxxxx xxxxx.
Submission xx xxxx xxxxxx xxxx xxx, xx itself, xxxxxxxxx x xxxxxxxxxx xx xxx xxxxxxxxxxxx xxx/xx authorized xxxxxxxxxxxxxx xx xxx xxxxxxxxx xxxxxxxxx that the xxxxxxx xx xxxx xxxxxx xx xxxxxxxx xx accurate, xxxx xxx xxxxxx(x) listed xxxxxx xx xxx xxxxxx xxx/xx that xxx xxxxxxx xxxxxx(x) xxxxxx xx xxxxxxxxxxx xx xxx alleged xxxxx or xxxxxxxxxxxxx xx the health xx xxx xxxxxx.
Xxxxxx xxxxxxxxxx, že xxxxxxx xxxxxxxxx xxxx xxxxxxx a xxxxxxxx.
X xxxxxx that xxx xxxxxxxxxxx xxxxx xxxxx xx xxxxxxx xx the xxxx xx xx xxxxxxxxx.
Xxxx ........................................... Datum ...................................
Xxxx Xxxx
Xxxxx, xxxxxxxx ........................... Xxxxxx ........................
Xxxx, xxxxxxx Signature
Xxxxxxxx x xxxx xxxxxxx:/Xxxxx and xxxxx xxxxxxxxxxx:9)
2700 | Procesní xxxxxxxx / Processing xxxxx xxxxxx příslušný xxxx – SÚKL / Xx be xxxxxx in xxxx xx xxx xxxxxxxxx xxxxxxxxx Xxxxx doručení xxxxxxxxxxx xxxxx / Xxxx xx delivery xx xxxxxxxxx authority6) | ||
2710 | Xxxxxxxxxx xxxxxxxxx / Preson xxxxxxxxxxx | 2920 | Xxxxxxx/Xxxxxxxxx xxxxxx |
2730 | Xxxxx xxxxxxx Xxxxxx xxxxxxxxxxxxxx informací a xxxxxxxxxxx/ Xxxx of xxxxxxxx xx xxxxxxxxx xx Xxxxxx Information xxx Xxxxxxxxxx6) | ||
Xxxxxx k xxxxxxxxxx xxxxxxxxx
Notes xx completing xxxx:
1) Xxxxxx xx x xxxxxxxxxxxx xxxx xxxxx (xxxxx ISO 3166), lomítka x (XXX) identifikačního xxxxx xxxxxxxx.
1) This xxxx xx xxxxxx xxxxxxxx xx xxx xxx-xxxxxxx country code xx xxxxxxxx XXX 3166 xxxxxxxx xx x xxxxx and xxx identity-number xx xxx xxxxxxx.
2) Xxxxxx xxxxxxx xxxx xxxxxxxxxxxx xxxxxxxx. Xxxxxxxx xx ode xxx xxxxxxxxx smlouvy o xxxxxxxxxxx České xxxxxxxxx xx Xxxxxxxx unie, xxxxx zdravotnický xxxxxxxxxx xxxxxxx xxxxxxxxx příhodou xx xxxxx v xxxxxxxx x členských xxxxx Evropských xxxxxxxxxxxx.
2) Xx be xxxxxx in by x xxxxxxxxxxxx xx xx en xxxxxxxxxx xxxxxxxxxxxxxx. Xx be xxxxxx xx from xxx xxx when x xxxxxxxx xxxxxxxxxx xxx xxxxxxxx xx xxx Czech Xxxxxxxx xxxx xxx Xxxxxxxx Xxxxx xx xxxxx, xxxxxxxxx that x xxxxxxx device xxxxxx xxxx xx an xxxxxxxx originated in xxxx of xxx xxxxxx xxxxxx xx xxx Xxxxxxxx Xxxxx.
3) Použijte xxxx xxx země v xxxxxxx s xxxxxx XXX 3166: 1993, xxxxxxxxx:
3) Please xxx the codes xxx the different xxxxxxxxx (acc. xx xxxxxxxx XXX 3166: 1993), x.x.:
XX ... Xxxxxxxx / Xxxxxxx XX ... Xxxxx / Xxxxxxx
BE ... Xxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxxxx
XX ... Xxxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxx
DK ... Xxxxxx / Xxxxxxx XX ... Xxxxxxxxxxxxxxx / Xxxxxxxxxxxxx
ES ... Xxxxxxxxx / Xxxxx XX ... Xxxxxxxxxxx / Xxxxxxxxxx
XX ... Xxxxxx / Xxxxxxx XX ... Xxxxxxxxxx / Netherlands
FR ... Xxxxxxx / Xxxxxx XX ... Norsko / Xxxxxx
XX ... Xxxxx Xxxxxxxx / United Xxxxxxx XX ... Portugalsko / Xxxxxxxx
XX ... Xxxxx / Xxxxxx XX ... Švédsko / Xxxxxx
4) Xxxxxxxx xxxx xxxxx podle Xxxxxxxx ČSÚ ze xxx 27.4.1999, xxxxxx 33/1999 Sb., x xxxxxxx xxxxx.
4) Xxxxxx xxx the xxxxxx xxxxx xxxxxxxxxx xx XXX Disposition xxxx 27.4.1999, part 33/1999 Xxxx. as xxxxxxx.
5) Xxxxxxx xxxxx x příjmení x xxxxxxx xxxxx, xxxxx xxxx xxxxxxxx xxxxx, xxx-xx x xxxxxxxxxx osobu.
5) Xxxxxx xxxxx a xxxxx name xxx x surname xx xxxx of x xxxxxxxx person, xxx xx case of x xxxxx xxxxxx xxx name xx x xxxx of x xxxxxxxxxx xxxxxxx.
6) Xxx, měsíc, xxx
6) Xxxx, xxxxx, xxx
7) Xxxxxxx xxxxxxx xxxx x xxxxx xxxxxxx xxxxxxxxxxxxxx prostředků podle Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxx (XXXXX) nebo xxxxx Xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx (XXXX), až xxxx x xxxxxxxxx (xxxx. 10966; xxxxxx, xxx).
7) Please xxxxx the xxxxxxxx xxxx and xxx xxxxxxxxxxx xxxx xxx xxxxxxxxxxxx Universal Medical Xxxxxx Xxxxxxxxxxxx System (XXXXX) xx Xxxxxx Xxxxxxx Xxxxxxx Xxxxxxxxxxxx (XXXX), xxxx xxxxx xx xxxxxxxxx (e.g. 10966; Xxxxxxxxxx, Xxxxx).
8) Xxxx a xxxxx xxxxxxxxx xxxx xxxxxxxx xx ČSN XX XXX 15225: 2000. Xxxxxxx se xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxx, xx xxxxx xxxxx x xxxxxx xx písmene x xx xxxxxxx X.
8) Xxxxxx xxxxxxxx code and xxxx are based xx XXX XX XXX 15225: 2000. Xxx device xxxxx xx xxxxxxxx xx xxx first category xx xxxxx xx xxxx, moving xxxx x xx I.
Xxx xxx. | Xxxxx xxxxxxxxx xxxxx. xxxxxxxxxx | X | Code of xxx. | Xxxx xx xxxxxxxx of xxxxxxx xxxxxxx | X |
06 | Xxxxxxxxxxxx xxxxxxxxxxxx prostředky xx xxxxx Xx xxxxx xxxxxxxxxx devices | x | 02 | Anestetické x xxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxxxxxxx / xxxxxxxxxxx xxxxxxx | x |
01 | Xxxxxxx implantabilní xxxxxxxxxxxx xxxxxxxxxx Active xxxxxxxxxxx xxxxxxx | x | 04 | Xxxxxxxxxxxxxxxxx zdravotnické xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxxx devices | x |
07 | Xxxxxxxxx implantabilní xxxxxxxxxxxxx xxxxxxxxxx Non-active xxxxxxxxxxx xxxxxxx | x | 09 | Xxxxxxxxxxxx xxxxxxxxxx – xxxxxxxx xxx xxxxxxxxx xxxxxxx Xxxxxxxx xxxxxxxxxxx | x |
03 | Xxxxxxxxxxxxxx zdravotnické xxxxxxxxxx Xxxxxx xxxxxxx | x | 10 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx Xxxxxx xxx devices | x |
08 | Xxxxxxxxxxxxxx x optické xxxxxxxxxxxx xxxxxxxxxx Xxxxxxxxx xxx xxxxxxx devices | x | 11 | Zdravotnické xxxxxxxxxx xxx xxxxxxxxx xxxxx Xxxxxxxxx xxxx for xxxxxxxx xxxxxxx | k |
12 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx x xxxxxxx xxxxxxx Xxxxxxxxxx xxx therapeutic xxxxxxxxx | x | 05 | Zdravotnické xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx Xxxxxxxx hardware | x |
9) X případě xxxxxxx xxxxxxxx xxxxx xxxx xxxxxx.
9) Xxx xxxxxxxxxx xxxxx xx necessary.
10) Xxxxxxx xxxxx x xxxxxxx, xx xxxxxx xxxxxx SÚKLu xxxxxxx xxxx xxxxxxxxxxxx xxxxxxxx.
10) Xx be xxxxxx xx xxxx xx xxxxxxxxxxxx / xxxxxxxxxx representative is xxxxxxxxx to XXXX.
11) X České xxxxxxxxx xxxxx x. 18/1997 Sb., x xxxxxxx xxxxxxxxx xxxxxxx xxxxxxx a ionizujícího xxxxxx (xxxxxxx zákon) x o xxxxx x doplnění xxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx předpisů.
11) Xx Xxxxx Xxxxxxxx Xxx Xx. 18/1997 Xxxx., on Xxxxxxxxx Xxxxxxxxxxx of Xxxxxxx Xxxxxx xxx lonising Xxxxxxxxx (Xxxxxx Xxx) xxx amendments xxx xxxxxxx xxxx Xxxx xx xxxxxxx.
12) X Xxxxx xxxxxxxxx xxxxx x. 123/2000 Xx., x xxxxxxxxxxxxxx xxxxxxxxxxxx x o xxxxx některých souvisejících xxxxxx, ve znění xxxxxx x. 130/2003 Xx.
12) Xx Xxxxx Xxxxxxxx Act Xx. 123/2000 Xxxx., xx Medical Xxxxxxx xxx xxxxxxxxxx xx xxxx related Xxxx xx xxxxxxx Act Xx. 130/2003 Xxxx.
13) X Xxxxx xxxxxxxxx xxxxx č. 22/1997 Sb., o xxxxxxxxxxx xxxxxxxxxxx na xxxxxxx x x xxxxx x xxxxxxxx xxxxxxxxx zákonů, xx xxxxx pozdějších xxxxxxxx.
13) Xx Czech Xxxxxxxx Xxx No. 22/1997 Xxxx., on Xxxxxxxxx Xxxxxxx xx Xxxxxxxx and amendments xxx addition xxxx Xxxx xx amended.
Příloha x. 2 x xxxxxxxx x. 501/2000 Xx.
Xxxxxxxx XX
xxx xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx prostředku
Xxxxxxxx Final Report Xxxx
3100 | Xxxxxxxxx xxxx provádějící xxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxx Xxx příslušného xxxxx / Code xx competent xxxxxxxxx XX/XX02 | ||
3110 | Název xxxxxxxxxxx xxxxx / Xxxx xx competent xxxxxxxxx Xxxxxx xxxxx xxx xxxxxxxx xxxxx (xxxx xxx „XXXX“) | ||
3120 | Xxxxx, číslo xxxx x/xxxx poštovní xxxxxxxx / Xxxxxx, xxxxx xxxxxx xxx/xx XX xxx Xxxxxxxxx 48 | ||
3130 | XXX / Xxxxxx code 100 41 | 3140 | Xxxx / Xxxx Xxxxx 10 |
3150 | Xxxxxxx / Xxxxxxxxx xxxxxx 272 185 780, 272 185 705 | 3160 | Fax / Xxx xxxxxx 272 185 764 |
3170 | E-Mail xxxx@xxxx.xx | 3180 | Xxxx / Xxxxxxx CZ |
3190 | Xxxxxxx xxx XXXX xx xxxxxxxx, xxxxx hlásí xxxxxxxxx xxxxxxx / Xxxxxx xx SÚKL xx xxxxxxx xxxxxxxxxx xxxxxxx incident Xxxxx xxxxxxxx, xxxxx xxxxxx xxxxxx / Xxxx xx xxxxxxx submitting xxxxxx | ||
3195 | Xxx xxxxxxx / Xxxx xx subject1) | ||
3200 | Xxxxxxx / Manufacturer Xxxxxxxx / Xxxx Xxxxxxxxxxxx xxxxxxxx / Xxxxxxxxxx xxxxxxxxxxxxxx2) Ostatní / Xxxxx Dovozce / Importer | ||
3210 | Xxxxx, xxxxx domu x/xxxx xxxxxxxx xxxxxxxx / Xxxxxx, xxxxx xxxxxx xxx/xx XX xxx | ||
3220 | XXX / Xxxxxx xxxx | 3230 | Xxxx / City |
3240 | Xxx státu / Xxxxxxx code 2) | 3250 | Xxx xxxxx / Xxxxxx code3) |
3260 | Xxxxx xxxxxxxxx xxxxx / Xxxx of xxxxxxx xxxxxx4) | ||
3270 | Xxxxxxx / Xxxxxxxxx xxxxxx | 3280 | Fax / Xxx number |
3290 | X-Xxxx | ||
3300 | Xxxxx xxxxxxx / Xxxx of report5) | ||
3310 | Xxxxx xxxxxxxxx příhody (xxxxxxxxx XXXX) Xxxxxxxx xxxxxx (processing xxxxxx xxxxxxxx by SÚKL) XX/XX02/..... |
3320 | Xxxxxxxxxxxx xxxxxxxxxx / Medical xxxxxx Xxxxx xxxxxxxxxxxxxx xxxxxxxxxx / Commercial xxxx of xxxxxxx xxxxxx |
3330 | Xxx xxxxxxx zdravotnického xxxxxxxxxx xxxxx UMDNS / GMDN7) XXXX / GMDN code xx xxxxxxx xxxxxx |
3340 | Xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx podle XXXXX / GMDN (např. xxxxxxxxxxxxxxxxx, vnější neivazivní)7) XXXXX / XXXX xxxxxxxxxxx of xxxxxxx xxxxxx xx Xxxxx (x.x. Xxxxxxxxxx, Xxxxxxx, Xxxxxxxx Xxxxxxxxxxx) |
3345 | Xxx kategorie xxxxxxxxxxxxxx xxxxxxxxxx8) Category xx xxxxxxx device |
3350 | Xxxxxxxx xxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxxx prostředku / Xxxxx xx catalogue xxxxxx |
3360 | Xxxxx(x) série xxxx xxxxx zdravotnického xxxxxxxxxx Xxxxxx xxxxxx(x) xx xxx xxxxxx(x) |
3370 | Příslušenství xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xx xxxxxxxx8) Xxxxxxxxxx xxxxxxx xxxxxxx/xxxxxxxxxxx (xx xxxxxxxxxx) |
3380 | Verze xxxxxxxxxxxx xxxxxxxx xxxxxxxx xx xxxxxxxx8) Xxxxxxxx xxxxxxx (if xxxxxxxxxx) |
3390 | Xxxxxxx / Xxxxxxxxxxxx Kód xxxxxxx / Xxxx xx xxxxxxxxxxxx1) |
3400 | Xxxxx xxxxxxx / Name xx xxxxxxxxxxxx4) |
3410 | Xxxxxxxxxxxxx xxxxx autorizované xxxxx, xxxxx xxxxx xxxxxxxxx. Xxxxxxxxxxxxxx xxxxxx xx Xxxxxxxx Xxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxxx. |
2410 | Hlásil xxxxx xxxxxxx již xxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx typu? Xxx the xxxxxxxxx xxxx previously reported xxxxxxxx xxxxxxxxx this xxxxxxx xxxxxx? xxx / yes xx /xx |
2420 | Xxxxx xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx / Date xx xxxxxx xx xxxxxxx xxxxxxxx5) |
2430 | Xxxxxxxx ano, xxx xx které xxxx (xx zemí XX, kde xx xxxxxxxxxxxx xxxxxxxxxx prodává)9) Xx xxx, xx xxxxx xxxxxxx (xxxxx XXX xxxxxxxxx xxxxx xxx medical xxxxxx xx xx sale) XX BE XX XX XX FI XX XX GR XX XX XX XX XX NL XX PT XX |
3450 | Xxxxxxx xxxxxxxxx xxxxxxx / závěry Xxxxxxxxxxxxx / conclusions Výsledek x xxxxx xxxxxxx xxxxxxxxxxx xxxxxxxx8) Xxxxxx xxx xxxxxxxxxx of xxxxxxxxxxxx´x xxxxxxxxxxxxx |
3460 | Další xxxxxxx xxxxxxxxx xxxxxxx (jestliže xxxx xxxxxxxxx)8) Further xxxxxxxxxxxxx (if any) |
3470 | Plánované xxxxxxxx xxxxxxxx (jestliže xxxx přijato)8) Xxxxxxx xxxxxxxxxx xxxxxx (xx xxx) |
3480 | Xxxxxx rozvrh xxxxxxxxxx xxxxxxxx / Xxxxxxx xxxxxxxx xx xxxxxxxxxx action (xx xxx) |
Xxxxxxxx/Xxxx:
Xxxxxxxxxx tohoto xxxxxxx xxxxxxxxxxxxx xxxxxxxxxx xxx xxxxx xxxxxxx nebo xxxx zplnomocněného xxxxxxxx xxx xxxxxxxxxxx úřadu x xxxxxxxx x xxxxxxxxx, xxx x xxx, že xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxx xxxx xxxxxxxx xxxx xxxxxxx x xxxxxxxx xxxxx xxxxxxxx xxxxx.
Xxxxxxxxxx xx xxxx xxxxxx xxxx xxx, xx xxxxxx, xxxxxxxxx x xxxxxxxxxx by xxx xxxxxxxxxxxx xxx/xx xxxxxxxxxx representative xx xxx xxxxxxxxx xxxxxxxxx xxxx the content xx this report xx xxxxxxxx xx xxxxxxxx, that xxx xxxxxx(x) xxxxxx xxxxxx xx xxx xxxxxx xxx/xx that xxx xxxxxxx device(s) caused xx xxxxxxxxxxx to xxx xxxxxxx xxxxx xx xxxxxxxxxxxxx xx xxx xxxxxx of xxx person.
Čestně xxxxxxxxxx, xx uvedené xxxxxxxxx xxxx xxxxxxx x pravdivé.
X xxxxxx xxxx xxx xxxxxxxxxxx xxxxx above xx xxxxxxx to xxx xxxx xx xx xxxxxxxxx.
Obec ........................................... Xxxxx ...................................
City Xxxx
Xxxxx, xxxxxxxx ........................... Xxxxxx ........................
Xxxx, xxxxxxx Xxxxxxxxx
Xxxxxxxx x xxxx xxxxxxx: / Notes xxx xxxxx xxxxxxxxxxx:8)
3490 | Xxxxxxxx poznámky / Processing notes Xxxxxx xxxxxxxxx xxxx / Xx xx xxxxxx xx xxxx xx xxx xxxxxxxxx xxxxxxxxx Xxxxx xxxxxxxx xxxxxxxxxxx úřadu / Xxxx xx xxxxxxxx xx xxxxxxxxx authority5) | ||
3500 | Xxxxxxxxxx xxxxxxxxx / Preson xxxxxxxxxxx | 3510 | Xxxxxxx/Xxxxxxxxx xxxxxx |
3520 | Xxxxx xxxxxxx Xxxxxx xxxxxxxxxxxxxx xxxxxxxxx x xxxxxxxxxxx5) | ||
Pokyny k xxxxxxxxxx xxxxxxxxx
Xxxxx xx completing form:
1) Skládá se x xxxxxxxxxxxx xxxx xxxxx (xxxxx ISO 3166), xxxxxxx x (XXX) xxxxxxxxxxxxxxx xxxxx xxxxxxxx.
1) Xxxx xxxx xx xxxxxx xxxxxxxx xx xxx xxx-xxxxxxx country code xx xxxxxxxx ISO 3166 xxxxxxxx xx x slash and xxx xxxxxxxx-xxxxxx of xxx xxxxxxx.
2) Xxxxxxxx xxxx xxx xxxx x xxxxxxx x xxxxxx ISO 3166: 1993, například:
2) Xxxxxx use xxx codes for xxx xxxxxxxxx xxxxxxxxx (xxx. to xxxxxxxx XXX 3166: 1993), x.x.:
XX ... Xxxxxxxx / Xxxxxxx XX ... Xxxxx / Ireland
XX ... Xxxxxx / Xxxxxxx XX ... Island / Xxxxxxx
XX ... Xxxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxx
XX ... Dánsko / Xxxxxxx XX ... Lichtenštejnsko / Liechtenstein
XX ... Xxxxxxxxx / Xxxxx XX ... Lucembursko / Xxxxxxxxxx
FI ... Xxxxxx / Xxxxxxx XX ... Xxxxxxxxxx / Xxxxxxxxxxx
XX ... Xxxxxxx / Xxxxxx XX ... Xxxxxx / Norway
XX ... Xxxxx Xxxxxxxx / Xxxxxx Kingdom XX ... Xxxxxxxxxxx / Xxxxxxxx
XX ... Xxxxx / Xxxxxx XX ... Xxxxxxx / Xxxxxx
3) Xxxxxxxx xxxx krajů xxxxx Xxxxxxxx XXX xx dne 27.4.1999, xxxxxx 33/1999 Xx., x platném xxxxx.
3) Please xxx xxx xxxxxx xxxxx xxxxxxxxxx xx XXX Xxxxxxxxxxx xxxx 27.4.1999, xxxx 33/1999 Xxxx. xx xxxxxxx.
4) Xxxxxxx xxxxx x xxxxxxxx x xxxxxxx xxxxx, xxxxx nebo xxxxxxxx xxxxx, xxx-xx x xxxxxxxxxx xxxxx.
4) Xxxxxx enter x xxxxx xxxx xxx a xxxxxxx xx xxxx xx x xxxxxxxx person, xxx xx case xx x legal xxxxxx its xxxx xx x name xx x xxxxxxxxxx xxxxxxx.
5) Rok, xxxxx, xxx
5) Xxxx, xxxxx, xxx
6) Xxxxxxx správné xxxx x název xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx Univerzálního xxxxxxxxxxxxxxx xxxxxxx (UMDNS) xxxx xxxxx Xxxxxxxx nomenklatury xxxxxxxxxxxxxx xxxxxxxxxx (XXXX), xx bude x xxxxxxxxx (xxxx. 10966; xxxxxx, mul).
6) Xxxxxx enter xxx xxxxxxxx xxxx xxx xxx designation xxxx xxx nomenclature Xxxxxxxxx Xxxxxxx Xxxxxx Nomenclature Xxxxxx (XXXXX) or Xxxxxx Xxxxxxx Xxxxxxx Xxxxxxxxxxxx (XXXX), when xxxxx xx xxxxxxxxx (x.x. 10966; Compresses, Xxxxx).
7) Xxxx x xxxxx kategorie xxxx xxxxxxxx xx XXX XX XXX 15225: 2000. Xxxxxxx xx xxxxxxxx xxxxx xxxxx xxxxxx kategorie, xx xxxxx xxxxx x pořadí xx xxxxxxx x xx xxxxxxx X.
7) Xxxxxx category xxxx xxx xxxx xxx xxxxx xx CSN XX XXX 15225: 2000. The xxxxxx xxxxx xx xxxxxxxx xx xxx first xxxxxxxx in xxxxx xx fits, xxxxxx xxxx x xx X.
Xxx xxx. | Xxxxx xxxxxxxxx zdrav. xxxxxxxxxx | X | Xxxx xx cat. | Xxxx xx xxxxxxxx xx xxxxxxx xxxxxxx | X |
06 | Xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xx xxxxx Xx xxxxx xxxxxxxxxx xxxxxxx | a | 02 | Xxxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxxxxxxx / respiratory xxxxxxx | x |
01 | Xxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxx prostředky Xxxxxx implantable xxxxxxx | x | 04 | Elektromechanické xxxxxxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx medical xxxxxxx | x |
07 | Xxxxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxxx xxxxxxxxxx Xxx-xxxxxx xxxxxxxxxxx xxxxxxx | x | 09 | Zdravotnické xxxxxxxxxx – nástroje xxx xxxxxxxxx xxxxxxx Xxxxxxxx xxxxxxxxxxx | i |
03 | Xxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Dental devices | x | 10 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx Xxxxxx use xxxxxxx | x |
08 | Xxxxxxxxxxxxxx a xxxxxxx xxxxxxxxxxxx prostředky Ophthamic xxx xxxxxxx xxxxxxx | x | 11 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx xxxxx Xxxxxxxxx xxxx xxx disabled xxxxxxx | x |
12 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx x terapii xxxxxxx Xxxxxxxxxx xxx therapeutic xxxxxxxxx | f | 05 | Xxxxxxxxxxxx xxxxxxxxxx v nemocničním xxxxxxxx Hospital xxxxxxxx | x |
8) V xxxxxxx xxxxxxx xxxxxxxx xxxxx xxxx papíru.
8) Use xxxxxxxxxx xxxxx if necessary.
9) Vyplní výrobce xxxx xxxxxxxxxxxx xxxxxxxx. Xxxxxxxx xx xxx xxx platnosti xxxxxxx x přistoupení Xxxxx xxxxxxxxx xx Evropské xxxx, xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxxx xx xxxxx x některém x xxxxxxxxx xxxxx Xxxxxxxxxx xxxxxxxxxxxx.
9) Xx xx xxxxxx xx xx x xxxxxxxxxxxx xx xx xx xxxxxxxxxx xxxxxxxxxxxxxx. Xx xx filled xx xxxx xxx xxx xxx when x xxxxxxxx xxxxxxxxxx xxx xxxxxxxx xx the Xxxxx Xxxxxxxx into xxx Xxxxxxxx Xxxxx xx xxxxx, xxxxxxxx xxxx a xxxxxxx xxxxxx taking part xx xx xxxxxxxx xxxxxxxxxx xx some xx xxx member xxxxxx xx xxx Xxxxxxxx Union.".
Xx. XX
Xxxx xxxxxxxx xxxxxx xxxxxxxxx xxxx 1. xxxxx 2003.
Xxxxxxxxxx:
MUDr. Xxxxxxxx x. r.
Xxxxxxxxx
Xxxxxx xxxxxxx x. 304/2003 Xx. xxxxx xxxxxxxxx xxxx 1.10.2003.
Právní xxxxxxx č. 304/2003 Xx. byl zrušen xxxxxxx xxxxxxxxx č. 268/2014 Sb. x účinností od 1.4.2015.
Xxxxx jednotlivých právních xxxxx jiných xxxxxxxx xxxxxxxx x xxxxxxxx xxxx aktualizováno, pokud xx jich netýká xxxxxxxxx změna xxxxx xxxxxxxxx právního xxxxxxxx.