Identity
- Trade Name
- MD medical mask EUDAMED
- Device Name
- MD medical mask EUDAMED
- Model / Reference
- MD-WL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806145489982 EUDAMED
- Basic UDI-DI
- 88061454MDM001GF EUDAMED
- Unit of Use DI
- 08806145490025 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
MD medical mask by DENTOS Inc. — 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 | 88061454MDM001GF | Class I | Active |
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Manufacturer
- Manufacturer
- Dentos Inc.
- EUDAMED SRN
- KR-MF-000002156
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 93c8a858-5cc9-4a1f-ab6f-6bf86800e8f0 61 fields · synced Jul 19, 2026