Identity
- Device Name
- Disposable Face Mask EUDAMED
- Model / Reference
- Rule 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974712704508 EUDAMED
- Basic UDI-DI
- 697471270TBKZ01PU EUDAMED
- Direct Marketing DI
- 06974712704508 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Disposable Face Mask by Ningbo Tianbo First Aid Product 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 | 697471270TBKZ01PU | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Tianbo First Aid Product Co., Ltd.
- EUDAMED SRN
- CN-MF-000016721
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 7ff07677-6b6a-4bfd-aea0-a48a5419c59e 61 fields · synced Jun 18, 2026