Identity
- Trade Name
- Incision Film 50x80cm EUDAMED
- Device Name
- ROUŠKY (BASE STATION DRAPE, ROUŠKA NA INSTRUMENTAČNÍ STŮL) / DRAPES (BASE STATION DRAPE, INSTRUMENT TABLE COVER) EUDAMED
- Model / Reference
- 122069011H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08596222865142 EUDAMED
- Basic UDI-DI
- 8596222doc048N3 EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Incision Film 50x80cm by BATIST Medical Productions s.r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8596222doc048N3 | Class I | Active |
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Manufacturer
- Manufacturer
- BATIST Medical Productions s.r.o.
- EUDAMED SRN
- CZ-MF-000023495
Sources (1)
- EUDAMED 45a12698-cac3-4108-b06a-1b1bc9d28108 61 fields · synced Jun 18, 2026