Identity
- Trade Name
- Drape 45x75cm, aperture diameter 7cm EUDAMED
- Device Name
- ROUŠKY VÍCEVRSTVÉ / MULTI-LAYERS DRAPE EUDAMED
- Model / Reference
- 1220692324B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08596222861076 EUDAMED
- Basic UDI-DI
- 8596222doc047MZ EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES 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
Drape 45x75cm, aperture diameter 7cm 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 | 8596222doc047MZ | Class I | Active |
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Manufacturer
- Manufacturer
- BATIST Medical Productions s.r.o.
- EUDAMED SRN
- CZ-MF-000023495
Sources (1)
- EUDAMED ecc2dbce-eda1-45c9-a26f-da3fe828f971 61 fields · synced Jun 18, 2026