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COPIOUMED Surgical Mask, Black, Tie-on style
EUDAMEDFDA UDIClass I (EU MDR)
Ref MS022BL
Identity
- Trade Name
- COPIOUMED Surgical Mask, Black, Tie-on style EUDAMEDCopioumed FDA UDI
- Generic Name
- Surgical/medical face mask, antimicrobial, single-use FDA UDI
- Device Name
- Surgical Mask EUDAMEDCopioumed Medical Mask is a disposable device intended to cover the mouth and nose of the user to contain that user’s respiratory secretions, it provides a barrier to reduce the risk of spread of infective agents between staff and patient and protect patient during surgical procedures and other medical settings. This device is non-sterile and for single use only. FDA UDI
- Model / Reference
- MS022BL EUDAMEDFDA UDI
- Description
- Copioumed Medical Mask is a disposable device intended to cover the mouth and nose of the user to contain that user’s respiratory secretions, it provides a barrier to reduce the risk of spread of infective agents between staff and patient and protect patient during surgical procedures and other medical settings. This device is non-sterile and for single use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719882250385 EUDAMED04719882250392 FDA UDI
- Basic UDI-DI
- 471988225MS02NH8 EUDAMED
- Unit of Use DI
- 04719882250392 EUDAMED
- FDA Product Code
- FXX FDA UDI
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
- GMDN Term
- Surgical/medical face mask, antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
COPIOUMED Surgical Mask, Black, Tie-on style by Copioumed International Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 471988225MS02NH8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Copioumed International Inc.
- EUDAMED SRN
- TW-MF-000011340
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 4a4382f7-d1a4-44c8-beac-283f71687418 61 fields · synced Jul 11, 2026
- FDA UDI 2fd81d1e-7e8a-48b6-b26d-81e41b43b742 34 fields · synced May 30, 2026