Identity
- Trade Name
- Medtecs CoverU Disposable 3 Ply Face Mask EUDAMED
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- FM-140G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710415369826 EUDAMED
- Basic UDI-DI
- 471041536FM013Q EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Medtecs CoverU Disposable 3 Ply Face Mask by Medtex Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471041536FM013Q | Class I | Active |
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Manufacturer
- Manufacturer
- Medtex Corporation
- EUDAMED SRN
- PH-MF-000022902
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED 808817ca-fb3d-4c4f-8bfa-6648d60387a9 61 fields · synced Jul 30, 2026