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Disposable Non-woven Surgical Face Mask
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 17.5*9.5cmModel ZB21C0607Ref N/A
Identity
- Device Name
- Disposable Non-woven Surgical Face Mask EUDAMED
- Model / Reference
- ZB21C0607 EUDAMED17.5*9.5cm EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973244780028 EUDAMED16973244780063 EUDAMED
- Basic UDI-DI
- 697324478mask0014Y EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Non-woven Surgical Face Mask by Xiantao Zhibo Non-woven Products 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 | K182514 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697324478mask0014Y | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Zhibo Non-woven Products Co., Ltd
- EUDAMED SRN
- CN-MF-000008760
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 3dfab02e-c93b-44ba-8b4b-808cbd2b0fbf 61 fields · synced Oct 6, 2026
- EUDAMED f5bb9b8a-33f9-4a73-9471-0f48aa4dfcf6 61 fields · synced May 17, 2026
- FDA 510(k) K182514 1 fields · synced May 18, 2026