Identity
- Trade Name
- Medical Face Mask EUDAMED
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- TX1299-2R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953102637497 EUDAMED
- Basic UDI-DI
- 69531026FMW0435ANS9H 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 Taizhou Xinkang Medical Materials 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 | 69531026FMW0435ANS9H | Class I | Active |
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Manufacturer
- Manufacturer
- Taizhou Xinkang Medical Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000012941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b0d20693-99e6-4d49-86d5-285d1440d84f 61 fields · synced Jun 18, 2026