Identity
- Device Name
- Medical Mask EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973509181003 EUDAMED
- Basic UDI-DI
- 697350918mask64 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 Mask by Xiantao Tongda Non-Woven 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 | 697350918mask64 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Tongda Non-woven Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000024554
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED c5c71507-67a0-4d5a-9f0b-63b5667eab43 61 fields · synced Jun 20, 2026