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Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref AM0425-4Model 17.5x9.5cm,12.5x8.5cm,14.5x9.5cm,16x9.5cm,16.5x9.5cm
Identity
- Trade Name
- Medical Face Mask EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- 17.5x9.5cm,12.5x8.5cm,14.5x9.5cm,16x9.5cm,16.5x9.5cm EUDAMEDAM0425-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973210340201 EUDAMED
- Basic UDI-DI
- 697321034facemaskQV EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Medical Face Mask 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 | 697321034facemaskQV | 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 61e6ee54-c14b-45a9-bcd9-35b85f1854c3 61 fields · synced Jun 14, 2026