Identity
- Trade Name
- Medical Disposable Face Mask EUDAMED
- Device Name
- Medical Disposable Face Mask EUDAMED
- Model / Reference
- TPS MK01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977143460067 EUDAMED
- Basic UDI-DI
- 697714346TPSMK01AE EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER 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 Disposable Face Mask by Hangzhou Tuopusi 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 | 697714346TPSMK01AE | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Tuopusi Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000039733
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED afddff14-e527-4d9c-a649-a9383eb1a375 61 fields · synced Oct 6, 2026