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Face masks
EUDAMEDClass I (EU MDR)
Ref GSModel GS、GM、GL、PS、PM、PL、GS1、GM1、GL1、PS1、PM1、PL1
Identity
- Trade Name
- Face masks EUDAMED
- Device Name
- Face masks EUDAMED
- Model / Reference
- GS、GM、GL、PS、PM、PL、GS1、GM1、GL1、PS1、PM1、PL1 EUDAMEDGS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971956735404 EUDAMED
- Basic UDI-DI
- 697195673540PQ EUDAMED
- Direct Marketing DI
- 06971956735404 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Face masks by Ningbo MFLAB Medical Instruments 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 | 697195673540PQ | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo MFLAB Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000032006
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 992b0e31-81ad-47f0-9acf-ffa915c1aa6e 61 fields · synced Jun 19, 2026