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OP-MASK B Face mask with elastic bands immunity
EUDAMEDClass I (EU MDR)
Ref 1320100629
Identity
- Trade Name
- OP-MASK B Face mask with elastic bands immunity EUDAMED
- Device Name
- ZDRAVOTNICKÉ OBLIČEJOVÉ MASKY / MEDICAL FACE MASKS EUDAMED
- Model / Reference
- 1320100629 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591454071415 EUDAMED
- Basic UDI-DI
- 8591454doc015MC EUDAMED
- EMDN Code
- T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) 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
OP-MASK B Face mask with elastic bands immunity by BATIST Medical a.s. — 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 | 8591454doc015MC | Class I | Active |
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Manufacturer
- Manufacturer
- BATIST Medical a.s.
- EUDAMED SRN
- CZ-MF-000023038
Sources (1)
- EUDAMED 06c15796-4f7c-4640-853c-bcb0684b8daf 61 fields · synced Jul 15, 2026