Identity
- Trade Name
- Bouffant caps non steril EUDAMED
- Device Name
- Medical cap EUDAMED
- Model / Reference
- Medical cap EUDAMED91001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 38834000176341 EUDAMED
- Basic UDI-DI
- 8834000176CA0001LG EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Bouffant caps non steril by Cobes Industries (bago) Company Limited — 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 | 8834000176CA0001LG | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries (bago) Company Limited
- EUDAMED SRN
- MM-MF-000012366
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 13329011-91b1-404e-b02d-7901a85572da 61 fields · synced Jun 20, 2026