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Cap
EUDAMEDClass I (EU MDR)
Ref 40078Model 40001, 40048, 40076, 40077, 40078, 90014
Identity
- Device Name
- Cap EUDAMED
- Model / Reference
- 40001, 40048, 40076, 40077, 40078, 90014 EUDAMED40078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973219622049 EUDAMED
- Basic UDI-DI
- 697321962102JN EUDAMED
- EMDN Code
- T0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Cap by Ammex-Weida (Hubei) Health and Safety 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 | 697321962102JN | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011701
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 16a7d79e-725b-4fe6-9cd3-f42f8cc598ec 61 fields · synced Oct 7, 2026