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Disposable surgical mask
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref Ear-loopRef Strappy
Identity
- Device Name
- Disposable surgical mask EUDAMED
- Model / Reference
- Ear-loop EUDAMEDStrappy EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16932141212787 EUDAMED16932141212794 EUDAMED
- Basic UDI-DI
- 697317895M66TK EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 surgical mask by Dongguan Shin Yi Healthcare Products Factory — 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 | K210372 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697317895M66TK | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Shin Yi Healthcare Products Factory
- EUDAMED SRN
- CN-MF-000020805
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 2cedd7cd-fa6a-41aa-8ca0-996c2cb27058 61 fields · synced Jul 24, 2026
- EUDAMED 550ae589-2039-423a-9ecc-4a7a7ee86f28 61 fields · synced May 18, 2026
- FDA 510(k) K210372 1 fields · synced May 18, 2026