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Bouffant cap
EUDAMEDClass I (EU MDR)
Ref AMG1522Model 18",19",21",22",24" any size can be customized
Identity
- Trade Name
- Bouffant cap EUDAMED
- Device Name
- Caps(Hoods) EUDAMED
- Model / Reference
- 18",19",21",22",24" any size can be customized EUDAMEDAMG1522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973210340461 EUDAMED
- Basic UDI-DI
- 697321034capshoods5G 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 Aimmax Medical 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 | 697321034capshoods5G | Class I | Active |
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Manufacturer
- Manufacturer
- Aimmax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000010875
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED b7cb8032-a266-4d25-864d-f9af7a20d4b0 61 fields · synced Jul 28, 2026