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Xian Wanli
EUDAMEDFDA UDIClass I (EU MDR)
Ref 17.5*9.5cmModel 17.5*9.5cm、14.5*9cm、21*7cm or customized
Identity
- Trade Name
- XIAN WANLI EUDAMEDFDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- Face Mask EUDAMED
- Model / Reference
- 17.5*9.5cm、14.5*9cm、21*7cm or customized EUDAMED17.5*9.5cm EUDAMEDWLM2002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973888820005 EUDAMEDFDA UDI
- Basic UDI-DI
- 697388882mask001GK EUDAMED
- 510(k) Number
- K210150 FDA UDI
- FDA Product Code
- FXX FDA UDI
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Xian Wanli by Hubei Wanli Protective Products Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697388882mask001GK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hubei Wanli Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000008182
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED d355884f-3534-471b-9833-4494b85d8aa9 61 fields · synced Jun 19, 2026
- FDA UDI 601dce47-d965-481c-af05-9a1f2ee9cada 33 fields · synced May 30, 2026