Identity
- Trade Name
- SAFEWEAR BOUFFANT CAP PP 15G/M² EUDAMEDBouffant cap EUDAMED
- Device Name
- Surcial cap with neck tie EUDAMED
- Model / Reference
- 70.010 EUDAMED404386 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973122517128 EUDAMED06973122512512 EUDAMED
- Basic UDI-DI
- 697312251CP1006Y EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDNorway 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
Safewear Bouffant Cap Pp 15g/M² by Crown Name Disposable Hygiene Products Fty. 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 | 697312251CP1006Y | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Crown Name Disposable Hygiene Products Fty. Ltd.
- EUDAMED SRN
- CN-MF-000008238
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED fa5a564e-0493-44ba-afdc-b2e9b232bf78 61 fields · synced Jul 15, 2026
- EUDAMED dc7503f6-25dc-4cd4-8626-fa7034981848 61 fields · synced Jul 15, 2026