Identity
- Device Name
- Medical Face Masks EUDAMED
- Model / Reference
- EN 14683 EUDAMEDM09322CM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976107140090 EUDAMED
- Basic UDI-DI
- 697610714N15N9 EUDAMED
- EMDN Code
- T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) 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 Masks by CareMax (Anhui) 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 | 697610714N15N9 | Class I | Active |
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Manufacturer
- Manufacturer
- CareMax (Anhui) Co., Ltd.
- EUDAMED SRN
- CN-MF-000035364
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 3d258a75-d8dd-470d-a996-2044c0d386ce 61 fields · synced Jul 15, 2026