Identity
- Trade Name
- U drape 150x180cm, split 20x30cm EUDAMED
- Device Name
- ROUŠKY VÍCEVRSTVÉ / MULTI-LAYERS DRAPE EUDAMED
- Model / Reference
- 1220692161B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08596222860253 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
U drape 150x180cm, split 20x30cm 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 3a122081-3085-4c5f-9f93-cc5eadf7b78b 61 fields · synced Jun 20, 2026