Identity
- Device Name
- Bouffant Cap EUDAMED
- Model / Reference
- Ref EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972841173455 EUDAMED
- Basic UDI-DI
- 697284117BC114AN EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER 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 Zhejiang Mediunion Healthcare Group 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 | 697284117BC114AN | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Mediunion Healthcare Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000026766
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED f3c1a7f1-4a1b-433d-b324-a558469b25fe 61 fields · synced Oct 6, 2026