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Nordiwell Surgical face mask
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 952001-70031
Identity
- Trade Name
- Nordiwell Surgical face mask EUDAMED
- Device Name
- medical face mask EUDAMED
- Model / Reference
- 952001-70031 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973458240196 EUDAMED
- Basic UDI-DI
- 697345824952001YF EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Nordiwell Surgical face mask by Changzhou Combat Protective Equipment Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210181 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697345824952001YF | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Combat Protective Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000016552
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED bf6656e7-1c49-4488-b2f4-e23f05ab2220 61 fields · synced Jun 19, 2026
- FDA 510(k) K210181 1 fields · synced May 18, 2026