Identity
- Trade Name
- Surgical Mask EUDAMEDV&Q FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Surgical Mask EUDAMEDNon Woven Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. FDA UDI
- Model / Reference
- VQN0185W EUDAMEDFDA UDI
- Description
- Non Woven Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970272170012 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970272170012 EUDAMED
- 510(k) Number
- K173062 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, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Surgical Mask by V&Q Manufacturing Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970272170012 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- V&Q Manufacturing Corporation
- EUDAMED SRN
- CN-MF-000018874
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 87252ae0-8503-4582-9728-f7d29f3e7255 61 fields · synced Jun 18, 2026
- FDA UDI 5648fedd-8a7e-4e2f-916a-1a1700173e49 35 fields · synced May 30, 2026