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Bouffant Cap
EUDAMEDClass I (EU MDR)
Ref Bouffant CapModel Mob Cap, Bouffant Cap, Doctor Cap with tiles, Doctor Cap with elastic
Identity
- Trade Name
- Bouffant Cap EUDAMED
- Device Name
- Cap EUDAMED
- Model / Reference
- Mob Cap, Bouffant Cap, Doctor Cap with tiles, Doctor Cap with elastic EUDAMEDBouffant Cap EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00697549344018 EUDAMED
- Basic UDI-DI
- 697549344CAPSQS EUDAMED
- Direct Marketing DI
- 00697549344018 EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Cap by Carestone Medical & Protective Products Co., Ltd. — 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 | 697549344CAPSQS | Class I | Active |
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Manufacturer
- Manufacturer
- Carestone Medical & Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000027756
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 8fcfa2f4-4488-4528-a2f5-1bec519f17ff 61 fields · synced Oct 9, 2026