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 xxx 3. xxxx 2003,
xxxxxx xx xxxx xxxxxxxx x. 501/2000 Sb., xxxxxx se xxxxxxx xxxxx, způsoby xxxxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxxxxx xxxxxxxxxx, jejich xxxxxxxxx, xxxxxxx a vyhodnocování, xxxxxxxxxxx x její xxxxxxxxxx a následné xxxxxxxxx x cílem xxxxxxxxxxx vzniku xxxxxxxxxxx xxxxxx, zejména xxxxxx xxxxxxxxx (xxxxxxxx x xxxxxxxxxxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx)
Xxxxxxxxxxxx xxxxxxxxxxxxx stanoví xxxxx §34 xxxxxx č. 123/2000 Xx., x xxxxxxxxxxxxxx xxxxxxxxxxxx x x změně xxxxxxxxxxxxx xxxxxx:
Xx. X
Xxxxxxx č. 1 x 2 x xxxxxxxx č. 501/2000 Sb., kterou xx xxxxxxx xxxxx, xxxxxxx xxxxxxxxxx xxxxxxxxxxx xxxxxx xxxxxxxxxxxxxx xxxxxxxxxx, xxxxxx evidování, xxxxxxx x vyhodnocování, xxxxxxxxxxx x její uchovávání x následné xxxxxxxxx x xxxxx xxxxxxxxxxx xxxxxx nežádoucích xxxxxx, xxxxxxx xxxxxx xxxxxxxxx (xxxxxxxx x nežádoucích xxxxxxxxx xxxxxxxxxxxxxx prostředků), xxxxx:
"Xxxxxxx x. 1 k vyhlášce x. 501/2000 Sb.
Xxxxxxxx X
xxx xxxxx xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx
Xxxxxxxx Initiral Report Xxxx
Xxxxxx x xxxxxxx xxxxxxxxx příhody
Xxxxx xx xxxxxxxxx xxxxxxxx
Xxxxxxx musí xxx podáno xxxxxxxxxx, x xxxx xxxxxx x xxxxxxxxx všechny xxxxxxxx xxxxxxxxx.
Xxx xxxxxx xxxxxx xx xxxx xx xxxx xx xxxxxxxx even xx xxx xxx xxx xxxxxxxxxxx xxxxxxxxx xxx xxx completion xx xxx form xx xxxxxxxxx.
2100 | Xxxxxxxxx xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxx detexting xxxxxxx xxxxxxxx Kód xxxxxxxxxxx xxxxx / Xxxx xx xxxxxxxxx xxxxxxxxx XX/XX02 | ||
2110 | Xxxxx xxxxxxxxxxx xxxxx / Xxxx xx xxxxxxxxx xxxxxxxxx Státní xxxxx pro kontrolu xxxxx (dále xxx „XXXX“) | ||
2120 | Xxxxx, xxxxx xxxx a/nebo xxxxxxxx schránky / Xxxxxx, xxxxx xxxxxx xxx/xx XX xxx Xxxxxxxxx 48 | ||
2130 | XXX / Xxxxxx xxxx 100 41 | 2140 | Xxxx / Xxxx Xxxxx 10 |
2150 | Telefon / Xxxxxxxxx number 272 185 780, 272&xxxx;185&xxxx;705 | 2160 | Xxx / Xxx number 272&xxxx;185&xxxx;764 |
2170 | X-Xxxx xxxx@xxxx.xx | 2180 | Xxxx / Xxxxxxx XX |
2190 | Xxxxxxx xxx SÚKL xx xxxxxxxx, xxxxx xxxxx xxxxxxxxx xxxxxxx / Report xx XXXX xx xxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxx Xxxxx subjektu, xxxxx xxxxxx xxxxxx / Xxxx xx xxxxxxx xxxxxxxxxx xxxxxx | ||
2195 | Xxx subjektu / Xxxx of subject1) | ||
2200 | Xxxxxxx / Xxxxxxxxxxxx Xxxxxxxx / User Xxxxxxxxxxxx xxxxxxxx / Xxxxxxxxxx xxxxxxxxxxxxxx2) Xxxxxxx / Xxxxx Xxxxxxx / Xxxxxxxx | ||
2210 | Xxxxx, xxxxx xxxx x/xxxx xxxxxxxx xxxxxxxx / Xxxxxx, xxxxx xxxxxx xxx/xx XX xxx | ||
2220 | PSČ / Xxxxxx xxxx | 2230 | Obec / Xxxx |
2240 | Xxx xxxxx / Xxxxxxx xxxx3) | 2250 | Xxx xxxxx / Xxxxxx xxxx4) |
2260 | Xxxxx xxxxxxxxx osoby / Name xx xxxxxxx xxxxxx5) | ||
2270 | Xxxxxxx / Xxxxxxxxx number | 2280 | Fax / Xxx xxxxxx |
2290 | X-Xxxx | 2230 | Datum xxxxxxx / Xxxx xx report6) |
2305 | Xxxxx xxxxxxxxx xxxxxxx (xxxxxxxxx XXXX) Incident xxxxxx (xxxxxxxxxx xxxxxx assigned xx XXXX) CZ/CA02/..... | ||
2310 | Xxxxxxxxxxxx prostředek / Xxxxxxx xxxxxx Xxxxx xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxxxxxxx name xx xxxxxxx xxxxxx |
2320 | Xxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx XXXXX / GMDN7) XXXX / GMDN xxxx xx medical device |
2330 | Xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx česky xxxxx XXXXX / XXXX (např. xxxxxxxxxxxxxxxxx, xxxxxx xxxxxxxxxx)7) XXXXX / GMDN xxxxxxxxxxx xx medical xxxxxx xx Czech (e.g. Xxxxxxxxxx, Xxxxxxx, External Xxxxxxxxxxx) |
2335 | Xxx xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx8) Xxxxxxxx xx medical xxxxxx |
2340 | Modelové xxxx katatlogové číslo xxxxxxxxxxxxxx prostředku / Xxxxx xx catalogue xxxxxx |
2350 | Xxxxx(x) xxxxx xxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxx(x) xx xxx xxxxxx(x) |
2360 | Xxxxxxxxxx zdravotnické xxxxxxxxxx / xxxxxxxxxxxxx (xxxxxxxx xx součástí)9) Xxxxxxxxxx xxxxxxx xxxxxxx / xxxxxxxxxxx (xx xxxxxxxxxx) |
2370 | Xxxxx xxxxxxxxxxxx vybavení (xxxxxxxx xx xxxxxxxx)9) Xxxxxxxx xxxxxxx (if applicable) |
2380 | Xxxxxxx / Xxxxxxxxxxxx Xxx xxxxxxx / Xxxx of manufacturer1) |
2390 | Jméno xxxxxxx / Name xx xxxxxxxxxxxx5) |
2400 | Xxxxxxxxxxxxx xxxxx autorizované xxxxx, xxxxx xxxxx xxxxxxxxx. Xxxxxxxxxxxxxx number xx Xxxxxxxx Xxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxxx. XX/XX...... |
2410 | Xxxxxx xxxxx xxxxxxx již xxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxx? Xxx xxx xxxxxxxxx xxxx previously xxxxxxxx xxxxxxxx xxxxxxxxx xxxx xxxxxxx xxxxxx? xxx / yes ne / xx |
2420 | Xxxxx xxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx / Xxxx xx xxxxxx xx xxxxxxx xxxxxxxx6) |
2430 | Jestliže xxx, xxx xx xxxxx xxxx (ze xxxx XX, xxx xx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx)2) Xx yes, xx xxxxx xxxxxxx (xxxxx XXX countries xxxxx xxx xxxxxxx xxxxxx xx on sale) XX XX DE XX XX XX XX XX XX XX IS XX XX XX NL XX PT SE |
2440 | Xxxxxxx xxxxxxx / Xxxxxx xx xxxxxxxxxxxx Xxxxxxx xxxxxxx zaslal (xxxxxxxx, kontaktní osoba, xxxx zdroj):10) Xxxxxx xx xxxxxxxxxxxx by (xxxx, xxxxxxx person xx xxxxx xxxxxx): |
2450 | Xxxxx, xxxxx xxxx x/xxxx xxxxx poštovní schránky / Street, xxxxx xxxxxx xxx/xx XX xxx |
2460 | XXX / Postal xxxx | 2470 | Xxxx / City |
2480 | Xxx xxxxx / Xxxxxxx3) | 2490 | Xxxx / Xxxxxx xxxx4) |
2500 | Xxxxxxx / Xxxxxxxxx xxxxxx | 2510 | Xxx / Xxx xxxxxx |
2520 | X-Xxxx | ||
2530 | Datum hlášení / Xxxx of xxxxxx6) | ||
2540 | Nežádoucí příhoda / Incident Xxxxx xxxxxxxxx xxxxxxx / Xxxx xx incident6) |
2550 | Místo xxxxxxxxx xxxxxxx / Xxxxx xx xxxxxxxx |
2560 | Popis xxxxxxxxx příhody / Xxxxxxxxxxx of xxxxxxxx9) |
2570 | Xxxxxxxx nežádoucí xxxxxxx (xxxx. úmrtí, xxxxxxxxx xxxxxx ...) Outcome xx xxx incident (x.x. xxxxx, xxxxxxxxxxxxx xx health ...) |
2580 | Xxxxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxxxx´x xxxxxxxxxx comment 9) |
2590 | Předpokládané xxxxx xxx závěrečné xxxxxxx xxxxxxxxx příhody / Xxxxxxxx xxxx of xxx incident follow-up xxxxxx6) |
2600 | Xxxxxxxxx nápravné opatření, xxxxxxxx bylo xxxxxxx9) Xxxxxxx xxxxxxxxxx xxxxxx (xx any) |
2610 | Xxxxxx xxxxxx xxxxxxxxxx xxxxxxxx / Xxxxxxx schedule |
2620 | Xxxxx x xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxxx / distribuovaném x Xxxxx republice Information xx xxxxxxx xxxxxxx xxxx / distributed xx xxx Czech Xxxxxxxx Xxxxxxxxx zdravotnický xxxxxxxxxx Custom-made xxxxxx ano/yes xx/xx |
2630 | Xxxx xxxxxxx xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx Xxxx of x xxxxxx or x procedure pack xxx/xxx xx/xx |
2640 | Xxxxxxxxxxxx xxxxxxxxxx x xxxxxx funkcí Xxxxxxx xxxxxx with xxxxxxxxx xxxxxxxx xxx/xxx xx/xx |
2650 | Zdravotnický xxxxxxxxxx, xx xxxxx xx xxxxxxxx x xxxxx xxxxxxxx xx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxx a ionizujícího xxxxxx x xxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx11) xxx/xxx xx/xx Xxxxxxx xxxxxx according xx xxx Xxx xx Xxxxxxxxx Xxxxxxxxxxx xx Xxxxxxx Energy |
2660 | Xxxxxxx udělená Xxxxxxxxxxxxx xxxxxxxxxxxxx xxxxx xxxxxx x xxxxxxxxxxxxxx xxxxxxxxxxxx12) xxx/xxx xx/xx Xxxxxxx approval xx Xxxxxxxx xx xxxxxx xxxxxxxxx to Xxxxxxx Xxxxxxx Xxx |
2670 | Xxxxxxxxx x zdravotnickém xxxxxxxxxx xxxxxxxxx Xxxxxxx xxxxxxxxxxx enclosed xxx/xxx xx/xx |
2680 | Zdravotnický xxxxxxxxxx xxxxxx xx xxx / Xxxxxxx xxxxxx xxxxxx xx xxx xxxxxx10) podle xxxxxx x technických xxxxxxxxxxx xx xxxxx zákona o xxxxxxxxxxxxxx xxxxxxxxxxxx12) xxxxxxx13) xxxxxxxxx xx xxx Xxx xx Xxxxxxxxx Xxxxxxx xxxxxxxxx to Xxxxxxx Devices Act xx Products |
2690 | Xxxxx xxxxx xxxx xxxxxxxxxxx? Which xxxxx Xxxxxxxxxxx xxxx notified? |
Xxxxxxxx/Xxxx:
Xxxxxxxxxx xxxxxx xxxxxxx nepředstavuje xxxxxxxxxx xxx závěr xxxxxxx xxxx xxxx xxxxxxxxxxxxxx xxxxxxxx xxx xxxxxxxxxxx xxxxx x xxxxxxxx x xxxxxxxxx, xxx x xxx, xx xxxxxxxxxxxx xxxxxxxxxx jakkoli xxxxxx xxxx xxxxxxxx xxxx xxxxxxx k xxxxxxxx xxxxx jakékoli xxxxx.
Xxxxxxxxxx xx xxxx xxxxxx does xxx, in xxxxxx, xxxxxxxxx x xxxxxxxxxx xx xxx manufacturer xxx/xx xxxxxxxxxx xxxxxxxxxxxxxx xx xxx xxxxxxxxx xxxxxxxxx that xxx xxxxxxx xx xxxx xxxxxx is xxxxxxxx xx accurate, that xxx xxxxxx(x) xxxxxx xxxxxx xx xxx xxxxxx and/or xxxx xxx medical xxxxxx(x) xxxxxx xx xxxxxxxxxxx xx xxx xxxxxxx xxxxx xx xxxxxxxxxxxxx xx xxx health xx xxx xxxxxx.
Xxxxxx xxxxxxxxxx, xx xxxxxxx xxxxxxxxx xxxx xxxxxxx x pravdivé.
X xxxxxx xxxx xxx xxxxxxxxxxx xxxxx xxxxx xx correst xx xxx xxxx xx my xxxxxxxxx.
Xxxx ........................................... Xxxxx ...................................
Xxxx Xxxx
Xxxxx, příjmení ........................... Xxxxxx ........................
Xxxx, xxxxxxx Xxxxxxxxx
Xxxxxxxx a jiné xxxxxxx:/Xxxxx and other xxxxxxxxxxx:9)
2700 | Procesní xxxxxxxx / Xxxxxxxxxx xxxxx vyplní příslušný xxxx – SÚKL / Xx xx xxxxxx xx xxxx xx the competent xxxxxxxxx Datum xxxxxxxx xxxxxxxxxxx xxxxx / Xxxx of xxxxxxxx xx competent xxxxxxxxx6) | ||
2710 | Xxxxxxxxxx xxxxxxxxx / Preson xxxxxxxxxxx | 2920 | Xxxxxxx/Xxxxxxxxx number |
2730 | Xxxxx xxxxxxx Ústavu xxxxxxxxxxxxxx informací x xxxxxxxxxxx/ Xxxx xx xxxxxxxx xx institute xx Xxxxxx Xxxxxxxxxxx xxx Statistics6) | ||
Xxxxxx x xxxxxxxxxx formuláře
Xxxxx xx xxxxxxxxxx xxxx:
1) Xxxxxx xx x xxxxxxxxxxxx xxxx xxxxx (xxxxx XXX 3166), xxxxxxx a (XXX) xxxxxxxxxxxxxxx xxxxx xxxxxxxx.
1) Xxxx xxxx is xxxxxx xxxxxxxx of xxx xxx-xxxxxxx xxxxxxx xxxx xx standard XXX 3166 followed xx x xxxxx xxx xxx xxxxxxxx-xxxxxx xx xxx subject.
2) Xxxxxx výrobce xxxx xxxxxxxxxxxx zástupce. Xxxxxxxx xx xxx xxx xxxxxxxxx xxxxxxx x xxxxxxxxxxx České xxxxxxxxx xx Evropské xxxx, xxxxx xxxxxxxxxxxx xxxxxxxxxx xxxxxxx nežádoucí xxxxxxxx xx původ x xxxxxxxx z xxxxxxxxx xxxxx Evropských xxxxxxxxxxxx.
2) To be xxxxxx in xx x manufacturer xx xx xx authorized xxxxxxxxxxxxxx. Xx xx xxxxxx xx from xxx xxx xxxx x contract xxxxxxxxxx xxx xxxxxxxx xx xxx Xxxxx Xxxxxxxx xxxx xxx Xxxxxxxx Xxxxx xx valid, xxxxxxxxx xxxx x xxxxxxx xxxxxx taking xxxx in xx xxxxxxxx originated in xxxx xx the xxxxxx states xx xxx Xxxxxxxx Xxxxx.
3) Použijte xxxx xxx země x xxxxxxx x xxxxxx XXX 3166: 1993, xxxxxxxxx:
3) Xxxxxx xxx xxx xxxxx xxx xxx xxxxxxxxx xxxxxxxxx (xxx. xx xxxxxxxx XXX 3166: 1993), x.x.:
XX ... Xxxxxxxx / Xxxxxxx XX ... Irsko / Xxxxxxx
XX ... Xxxxxx / Belgium XX ... Island / Xxxxxxx
DE ... Xxxxxxx / Xxxxxxx XX ... Xxxxxx / Xxxxx
XX ... Xxxxxx / Xxxxxxx XX ... Lichtenštejnsko / Xxxxxxxxxxxxx
ES ... Xxxxxxxxx / Xxxxx XX ... Xxxxxxxxxxx / Xxxxxxxxxx
XX ... Finsko / Xxxxxxx XX ... Xxxxxxxxxx / Netherlands
XX ... Xxxxxxx / France XX ... Xxxxxx / Xxxxxx
GB ... Xxxxx Xxxxxxxx / United Xxxxxxx XX ... Portugalsko / Portugal
XX ... Xxxxx / Xxxxxx XX ... Xxxxxxx / Xxxxxx
4) Použijte xxxx xxxxx podle Xxxxxxxx XXX ze xxx 27.4.1999, xxxxxx 33/1999 Xx., v xxxxxxx xxxxx.
4) Xxxxxx xxx xxx xxxxxx xxxxx xxxxxxxxxx xx XXX Disposition xxxx 27.4.1999, xxxx 33/1999 Xxxx. xx xxxxxxx.
5) Vyplňte xxxxx x xxxxxxxx x xxxxxxx xxxxx, xxxxx nebo obchodní xxxxx, xxx-xx x xxxxxxxxxx xxxxx.
5) Xxxxxx enter x xxxxx xxxx and x xxxxxxx xx xxxx xx x xxxxxxxx person, xxx xx xxxx xx x xxxxx xxxxxx xxx xxxx xx x xxxx xx x commercial xxxxxxx.
6) Rok, xxxxx, xxx
6) Year, xxxxx, xxx
7) Xxxxxxx správné xxxx x xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx podle Xxxxxxxxxxxxx xxxxxxxxxxxxxxx systému (XXXXX) xxxx podle Xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx (XXXX), až xxxx x xxxxxxxxx (xxxx. 10966; xxxxxx, xxx).
7) Please xxxxx xxx relevant xxxx xxx xxx xxxxxxxxxxx xxxx xxx xxxxxxxxxxxx Xxxxxxxxx Xxxxxxx Xxxxxx Nomenclature System (XXXXX) xx Xxxxxx Xxxxxxx Xxxxxxx Xxxxxxxxxxxx (XXXX), when xxxxx xx available (x.x. 10966; Compresses, Xxxxx).
8) Xxxx x xxxxx kategorie jsou xxxxxxxx na XXX XX XXX 15225: 2000. Xxxxxxx xx xxxxxxxx xxxxx první xxxxxx xxxxxxxxx, do xxxxx xxxxx v xxxxxx xx písmene x xx xxxxxxx X.
8) Xxxxxx xxxxxxxx xxxx xxx xxxx are xxxxx xx CSN EN XXX 15225: 2000. Xxx xxxxxx xxxxx xx xxxxxxxx xx xxx first category xx xxxxx xx xxxx, moving from x to X.
Xxx xxx. | Xxxxx xxxxxxxxx xxxxx. xxxxxxxxxx | X | Xxxx of xxx. | Xxxx of xxxxxxxx xx medical xxxxxxx | X |
06 | Xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx xx xxxxx Xx xxxxx xxxxxxxxxx xxxxxxx | x | 02 | Anestetické x xxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Anaesthetic / xxxxxxxxxxx xxxxxxx | x |
01 | Aktivní xxxxxxxxxxxxx xxxxxxxxxxxx prostředky Xxxxxx xxxxxxxxxxx devices | x | 04 | Xxxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxxx devices | x |
07 | Xxxxxxxxx implantabilní xxxxxxxxxxxxx prostředky Xxx-xxxxxx xxxxxxxxxxx devices | x | 09 | Zdravotnické xxxxxxxxxx – xxxxxxxx pro xxxxxxxxx použití Reusable xxxxxxxxxxx | i |
03 | Xxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxx | x | 10 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx xxxxxxx Xxxxxx xxx xxxxxxx | x |
08 | Xxxxxxxxxxxxxx x xxxxxxx zdravotnické xxxxxxxxxx Ophthamic xxx xxxxxxx xxxxxxx | e | 11 | Zdravotnické prostředky xxx xxxxxxxxx xxxxx Xxxxxxxxx xxxx xxx xxxxxxxx persons | k |
12 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx a xxxxxxx xxxxxxx Diagnostic xxx xxxxxxxxxxx radiation | x | 05 | Xxxxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx Xxxxxxxx hardware | l |
9) X případě xxxxxxx použijte xxxxx xxxx xxxxxx.
9) Xxx xxxxxxxxxx sheet xx necessary.
10) Xxxxxxx xxxxx x xxxxxxx, xx xxxxxx xxxxxx XXXXx výrobce xxxx zplnomocněný zástupce.
10) Xx xx xxxxxx xx xxxx xx manufacturer / xxxxxxxxxx representative xx xxxxxxxxx xx XXXX.
11) V Xxxxx xxxxxxxxx xxxxx x. 18/1997 Sb., o xxxxxxx xxxxxxxxx xxxxxxx xxxxxxx a xxxxxxxxxxxx xxxxxx (xxxxxxx xxxxx) x x změně x xxxxxxxx některých xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx.
11) Xx Xxxxx Xxxxxxxx Xxx Xx. 18/1997 Xxxx., xx Xxxxxxxxx Xxxxxxxxxxx xx Xxxxxxx Xxxxxx and xxxxxxxx Xxxxxxxxx (Xxxxxx Xxx) xxx xxxxxxxxxx xxx xxxxxxx xxxx Xxxx xx amended.
12) X Xxxxx xxxxxxxxx xxxxx x. 123/2000 Xx., x xxxxxxxxxxxxxx xxxxxxxxxxxx a o xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, ve znění xxxxxx x. 130/2003 Xx.
12) Xx Xxxxx Xxxxxxxx Xxx Xx. 123/2000 Xxxx., xx Xxxxxxx Xxxxxxx xxx xxxxxxxxxx to xxxx xxxxxxx Acts xx xxxxxxx Xxx Xx. 130/2003 Coll.
13) V České xxxxxxxxx zákon č. 22/1997 Xx., x xxxxxxxxxxx xxxxxxxxxxx xx xxxxxxx x x xxxxx a xxxxxxxx xxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx.
13) In Xxxxx Xxxxxxxx Xxx No. 22/1997 Xxxx., xx Xxxxxxxxx Xxxxxxx xx Xxxxxxxx xxx amendments xxx addition xxxx Xxxx xx xxxxxxx.
Xxxxxxx x. 2 x xxxxxxxx x. 501/2000 Sb.
Xxxxxxxx II
pro xxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx prostředku
Xxxxxxxx Xxxxx Report Xxxx
3100 | Xxxxxxxxx xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx xxxxxxx / Xxxxxxxxxx detexting initial xxxxxxxx Xxx xxxxxxxxxxx xxxxx / Xxxx xx xxxxxxxxx xxxxxxxxx XX/XX02 | ||
3110 | Xxxxx xxxxxxxxxxx úřadu / Xxxx xx xxxxxxxxx xxxxxxxxx Xxxxxx xxxxx xxx xxxxxxxx léčiv (xxxx jen „SÚKL“) | ||
3120 | Xxxxx, číslo xxxx x/xxxx poštovní xxxxxxxx / Street, xxxxx xxxxxx xxx/xx XX xxx Xxxxxxxxx 48 | ||
3130 | XXX / Postal xxxx 100 41 | 3140 | Xxxx / Xxxx Xxxxx 10 |
3150 | Xxxxxxx / Xxxxxxxxx xxxxxx 272&xxxx;185&xxxx;780, 272 185 705 | 3160 | Fax / Xxx xxxxxx 272 185 764 |
3170 | E-Mail xxxx@xxxx.xx | 3180 | Stát / Xxxxxxx CZ |
3190 | Xxxxxxx xxx XXXX xx xxxxxxxx, který xxxxx xxxxxxxxx xxxxxxx / Xxxxxx xx SÚKL xx xxxxxxx xxxxxxxxxx xxxxxxx xxxxxxxx Název xxxxxxxx, který xxxxxx xxxxxx / Xxxx xx subject xxxxxxxxxx xxxxxx | ||
3195 | Xxx xxxxxxx / Xxxx of subject1) | ||
3200 | Xxxxxxx / Manufacturer Xxxxxxxx / Xxxx Xxxxxxxxxxxx xxxxxxxx / Xxxxxxxxxx xxxxxxxxxxxxxx2) Xxxxxxx / Xxxxx Xxxxxxx / Importer | ||
3210 | Xxxxx, xxxxx domu x/xxxx poštovní xxxxxxxx / Xxxxxx, house xxxxxx xxx/xx XX xxx | ||
3220 | XXX / Xxxxxx xxxx | 3230 | Xxxx / Xxxx |
3240 | Kód xxxxx / Xxxxxxx code 2) | 3250 | Xxx xxxxx / Xxxxxx xxxx3) |
3260 | Xxxxx xxxxxxxxx osoby / Name of xxxxxxx xxxxxx4) | ||
3270 | Xxxxxxx / Xxxxxxxxx xxxxxx | 3280 | Fax / Xxx xxxxxx |
3290 | X-Xxxx | ||
3300 | Xxxxx xxxxxxx / Xxxx of xxxxxx5) | ||
3310 | Xxxxx xxxxxxxxx xxxxxxx (xxxxxxxxx XXXX) Incident xxxxxx (xxxxxxxxxx xxxxxx xxxxxxxx xx XXXX) XX/XX02/..... |
3320 | Xxxxxxxxxxxx xxxxxxxxxx / Xxxxxxx xxxxxx Xxxxx xxxxxxxxxxxxxx xxxxxxxxxx / Xxxxxxxxxx xxxx of xxxxxxx xxxxxx |
3330 | Xxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxx UMDNS / GMDN7) XXXX / XXXX xxxx xx medical xxxxxx |
3340 | Xxxxx xxxxxxx zdravotnického xxxxxxxxxx xxxxx podle XXXXX / XXXX (xxxx. xxxxxxxxxxxxxxxxx, xxxxxx xxxxxxxxxx)7) XXXXX / XXXX xxxxxxxxxxx xx medical xxxxxx xx Czech (x.x. Pacemakers, Cardiac, Xxxxxxxx Xxxxxxxxxxx) |
3345 | Xxx xxxxxxxxx xxxxxxxxxxxxxx prostředku8) Category xx medical xxxxxx |
3350 | Modelové xxxx xxxxxxxxxxx číslo xxxxxxxxxxxxxx prostředku / Xxxxx xx xxxxxxxxx xxxxxx |
3360 | Xxxxx(x) série nebo xxxxx xxxxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxx(x) or xxx number(s) |
3370 | Xxxxxxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx je xxxxxxxx8) Xxxxxxxxxx medical xxxxxxx/xxxxxxxxxxx (if applicable) |
3380 | Verze xxxxxxxxxxxx xxxxxxxx xxxxxxxx xx součástí8) Software xxxxxxx (if xxxxxxxxxx) |
3390 | Xxxxxxx / Xxxxxxxxxxxx Kód xxxxxxx / Xxxx of xxxxxxxxxxxx1) |
3400 | Jméno xxxxxxx / Xxxx xx xxxxxxxxxxxx4) |
3410 | Xxxxxxxxxxxxx xxxxx xxxxxxxxxxxx xxxxx, která xxxxx xxxxxxxxx. Xxxxxxxxxxxxxx xxxxxx xx Norified Xxxx xxxxxxxx xx xxxxxxxxxx xxxxxxxxxx. |
2410 | Hlásil xxxxx xxxxxxx xxx xxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx xxxx? Xxx xxx xxxxxxxxx xxxx xxxxxxxxxx reported xxxxxxxx involving xxxx xxxxxxx xxxxxx? xxx / xxx xx /xx |
2420 | Datum xxxxxxx xxxxxxxx nežádoucí xxxxxxx / Date xx report xx xxxxxxx xxxxxxxx5) |
2430 | Xxxxxxxx xxx, xxx xx xxxxx xxxx (xx zemí XX, xxx se xxxxxxxxxxxx prostředek xxxxxxx)9) Xx xxx, xx xxxxx xxxxxxx (xxxxx XXX xxxxxxxxx xxxxx xxx medical xxxxxx xx xx xxxx) XX BE XX XX ES FI XX XX XX XX XX XX XX LU NL XX XX XX |
3450 | Xxxxxxx xxxxxxxxx xxxxxxx / xxxxxx Xxxxxxxxxxxxx / conclusions Výsledek x závěr šetření xxxxxxxxxxx xxxxxxxx8) Result xxx xxxxxxxxxx xx xxxxxxxxxxxx´x investigation |
3460 | Xxxxx xxxxxxx xxxxxxxxx příhody (xxxxxxxx xxxx provedeno)8) Further xxxxxxxxxxxxx (xx xxx) |
3470 | Plánované xxxxxxxx xxxxxxxx (xxxxxxxx xxxx přijato)8) Xxxxxxx xxxxxxxxxx xxxxxx (xx xxx) |
3480 | Xxxxxx rozvrh xxxxxxxxxx xxxxxxxx / Xxxxxxx xxxxxxxx xx xxxxxxxxxx action (if xxx) |
Poznámka/Note:
Xxxxxxxxxx xxxxxx xxxxxxx xxxxxxxxxxxxx xxxxxxxxxx xxx xxxxx výrobce xxxx xxxx xxxxxxxxxxxxxx xxxxxxxx xxx příslušného xxxxx x xxxxxxxx x xxxxxxxxx, ani o xxx, xx xxxxxxxxxxxx xxxxxxxxxx jakkoli selhal xxxx způsobil nebo xxxxxxx x zhoršení xxxxx xxxxxxxx xxxxx.
Xxxxxxxxxx xx this xxxxxx xxxx xxx, xx xxxxxx, xxxxxxxxx x xxxxxxxxxx by xxx manufacturer xxx/xx xxxxxxxxxx xxxxxxxxxxxxxx xx xxx xxxxxxxxx authority xxxx xxx content xx this report xx xxxxxxxx xx xxxxxxxx, that xxx xxxxxx(x) xxxxxx xxxxxx xx xxx xxxxxx xxx/xx that the xxxxxxx xxxxxx(x) caused xx xxxxxxxxxxx xx xxx xxxxxxx xxxxx xx xxxxxxxxxxxxx in xxx health xx xxx xxxxxx.
Xxxxxx xxxxxxxxxx, že uvedené xxxxxxxxx xxxx xxxxxxx x xxxxxxxx.
X xxxxxx xxxx xxx xxxxxxxxxxx xxxxx xxxxx xx xxxxxxx xx xxx xxxx xx xx knowledge.
Obec ........................................... Xxxxx ...................................
City Xxxx
Xxxxx, xxxxxxxx ........................... Xxxxxx ........................
Xxxx, xxxxxxx Xxxxxxxxx
Xxxxxxxx x jiná xxxxxxx: / Xxxxx xxx other information:8)
3490 | Procesní xxxxxxxx / Xxxxxxxxxx xxxxx Xxxxxx xxxxxxxxx úřad / Xx xx xxxxxx xx xxxx xx xxx competent xxxxxxxxx Xxxxx doručení xxxxxxxxxxx úřadu / Xxxx xx xxxxxxxx xx xxxxxxxxx xxxxxxxxx5) | ||
3500 | Xxxxxxxxxx xxxxxxxxx / Xxxxxx xxxxxxxxxxx | 3510 | Xxxxxxx/Xxxxxxxxx xxxxxx |
3520 | Xxxxx xxxxxxx Ústavu xxxxxxxxxxxxxx informací x xxxxxxxxxxx5) | ||
Xxxxxx k xxxxxxxxxx xxxxxxxxx
Xxxxx xx completing xxxx:
1) Skládá xx x xxxxxxxxxxxx xxxx xxxxx (xxxxx XXX 3166), xxxxxxx a (XXX) xxxxxxxxxxxxxxx xxxxx xxxxxxxx.
1) Xxxx xxxx is always xxxxxxxx of the xxx-xxxxxxx xxxxxxx xxxx xx standard XXX 3166 followed xx x slash xxx xxx xxxxxxxx-xxxxxx xx xxx xxxxxxx.
2) Xxxxxxxx kódy pro xxxx x xxxxxxx x xxxxxx ISO 3166: 1993, xxxxxxxxx:
2) Please use xxx xxxxx xxx xxx xxxxxxxxx xxxxxxxxx (xxx. to standard XXX 3166: 1993), x.x.:
XX ... Xxxxxxxx / Xxxxxxx XX ... Xxxxx / Xxxxxxx
XX ... Xxxxxx / Xxxxxxx IS ... Xxxxxx / Xxxxxxx
XX ... Xxxxxxx / Xxxxxxx XX ... Itálie / Italy
DK ... Xxxxxx / Xxxxxxx LI ... Lichtenštejnsko / Liechtenstein
ES ... Xxxxxxxxx / Xxxxx XX ... Xxxxxxxxxxx / Xxxxxxxxxx
XX ... Xxxxxx / Xxxxxxx XX ... Xxxxxxxxxx / Xxxxxxxxxxx
XX ... Xxxxxxx / Xxxxxx XX ... Xxxxxx / Xxxxxx
GB ... Xxxxx Xxxxxxxx / Xxxxxx Kingdom XX ... Xxxxxxxxxxx / Portugal
XX ... Xxxxx / Xxxxxx XX ... Xxxxxxx / Xxxxxx
3) Xxxxxxxx xxxx xxxxx xxxxx Xxxxxxxx ČSÚ xx xxx 27.4.1999, xxxxxx 33/1999 Xx., x xxxxxxx xxxxx.
3) Xxxxxx xxx xxx xxxxxx xxxxx xxxxxxxxxx xx CSO Xxxxxxxxxxx from 27.4.1999, xxxx 33/1999 Xxxx. xx amended.
4) Xxxxxxx xxxxx x xxxxxxxx u fyzické xxxxx, xxxxx xxxx xxxxxxxx xxxxx, xxx-xx x xxxxxxxxxx xxxxx.
4) Xxxxxx xxxxx x xxxxx name xxx x xxxxxxx xx case xx x physical person, xxx xx xxxx xx x legal xxxxxx xxx xxxx xx x name xx x xxxxxxxxxx xxxxxxx.
5) Xxx, xxxxx, xxx
5) Xxxx, month, day
6) Xxxxxxx xxxxxxx xxxx a xxxxx xxxxxxx zdravotnických xxxxxxxxxx xxxxx Xxxxxxxxxxxxx nomenklaturního xxxxxxx (UMDNS) xxxx xxxxx Xxxxxxxx xxxxxxxxxxxx xxxxxxxxxxxxxx prostředků (GMDN), xx bude x xxxxxxxxx (xxxx. 10966; xxxxxx, xxx).
6) Xxxxxx xxxxx the xxxxxxxx xxxx and xxx xxxxxxxxxxx xxxx xxx xxxxxxxxxxxx Universal Xxxxxxx Xxxxxx Xxxxxxxxxxxx Xxxxxx (XXXXX) or Xxxxxx Xxxxxxx Xxxxxxx Xxxxxxxxxxxx (XXXX), xxxx xxxxx is available (x.x. 10966; Xxxxxxxxxx, Xxxxx).
7) Kódy x název xxxxxxxxx xxxx xxxxxxxx na XXX XX XXX 15225: 2000. Výrobek xx xxxxxxxx kódem xxxxx xxxxxx kategorie, xx xxxxx xxxxx x pořadí xx xxxxxxx x do xxxxxxx X.
7) Xxxxxx xxxxxxxx xxxx xxx term are xxxxx xx XXX XX XXX 15225: 2000. Xxx device xxxxx be assigned xx xxx xxxxx xxxxxxxx in which xx xxxx, moving xxxx x xx X.
Xxx xxx. | Xxxxx xxxxxxxxx xxxxx. xxxxxxxxxx | X | Xxxx xx xxx. | Xxxx xx xxxxxxxx xx xxxxxxx devices | X |
06 | Xxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx in xxxxx Xx xxxxx diagnostic xxxxxxx | x | 02 | Xxxxxxxxxxx x xxxxxxxxxx xxxxxxxxxxxx prostředky Xxxxxxxxxxx / respiratory devices | x |
01 | Xxxxxxx xxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxxxxxx xxxxxxx | x | 04 | Xxxxxxxxxxxxxxxxx xxxxxxxxxxxx prostředky Xxxxxxx xxxxxxxxxx xxxxxxx devices | x |
07 | Neaktivní xxxxxxxxxxxxx xxxxxxxxxxxxx xxxxxxxxxx Xxx-xxxxxx xxxxxxxxxxx xxxxxxx | x | 09 | Xxxxxxxxxxxx xxxxxxxxxx – xxxxxxxx xxx xxxxxxxxx použití Xxxxxxxx xxxxxxxxxxx | x |
03 | Xxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxx xxxxxxx | x | 10 | Xxxxxxxxxxxx xxxxxxxxxx xxx jednorázové xxxxxxx Xxxxxx xxx xxxxxxx | x |
08 | Xxxxxxxxxxxxxx x xxxxxxx xxxxxxxxxxxx xxxxxxxxxx Xxxxxxxxx xxx xxxxxxx xxxxxxx | x | 11 | Zdravotnické xxxxxxxxxx pro postižené xxxxx Xxxxxxxxx xxxx xxx xxxxxxxx xxxxxxx | x |
12 | Xxxxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxxxx x terapii zářením Xxxxxxxxxx xxx xxxxxxxxxxx xxxxxxxxx | x | 05 | Xxxxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxx xxxxxxxx Xxxxxxxx xxxxxxxx | x |
8) V xxxxxxx xxxxxxx xxxxxxxx xxxxx xxxx xxxxxx.
8) Xxx xxxxxxxxxx xxxxx xx xxxxxxxxx.
9) Vyplní xxxxxxx xxxx zplnomocněný zástupce. Xxxxxxxx se ode xxx xxxxxxxxx xxxxxxx x xxxxxxxxxxx Xxxxx xxxxxxxxx xx Xxxxxxxx xxxx, pokud xxxxxxxxxxxx xxxxxxxxxx dotčený nežádoucí xxxxxxxx xx původ x xxxxxxxx z xxxxxxxxx států Evropských xxxxxxxxxxxx.
9) Xx xx xxxxxx xx xx a xxxxxxxxxxxx xx by xx xxxxxxxxxx xxxxxxxxxxxxxx. Xx xx filled xx xxxx xxx xxx xxx xxxx a xxxxxxxx concerning xxx xxxxxxxx xx xxx Xxxxx Xxxxxxxx xxxx xxx Xxxxxxxx Xxxxx xx valid, xxxxxxxx xxxx a xxxxxxx xxxxxx xxxxxx part xx xx incident xxxxxxxxxx xx xxxx xx the xxxxxx xxxxxx xx xxx Xxxxxxxx Xxxxx.".
Čl. XX
Xxxx xxxxxxxx xxxxxx xxxxxxxxx dnem 1. xxxxx 2003.
Xxxxxxxxxx:
MUDr. Xxxxxxxx x. r.
Xxxxxxxxx
Xxxxxx xxxxxxx x. 304/2003 Xx. nabyl xxxxxxxxx xxxx 1.10.2003.
Xxxxxx xxxxxxx x. 304/2003 Xx. byl xxxxxx xxxxxxx xxxxxxxxx č. 268/2014 Sb. x xxxxxxxxx od 1.4.2015.
Xxxxx jednotlivých xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx v xxxxxxxx xxxx xxxxxxxxxxxxx, pokud xx xxxx xxxxxx xxxxxxxxx xxxxx shora xxxxxxxxx právního xxxxxxxx.