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Bouffant cap
EUDAMEDClass I (EU MDR)
Ref HY-500152Model Non sterile dressing
by Hygitech
Identity
- Trade Name
- Bouffant cap EUDAMED
- Model / Reference
- Non sterile dressing EUDAMEDHY-500152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615140006699 EUDAMED
- Basic UDI-DI
- 361514H2PROT11629 EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Hygitech — 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 | 361514H2PROT11629 | Class I | Active |
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Manufacturer
- Manufacturer
- Hygitech
- EUDAMED SRN
- FR-MF-000007549
Sources (1)
- EUDAMED 51b543c7-6771-41c9-9605-1f527589fa44 61 fields · synced Jul 10, 2026