Identity
- Trade Name
- Surgical Mask EUDAMED
- Device Name
- Surgical Mask EUDAMED
- Model / Reference
- 69-8110-G EUDAMED69-8310-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 74895237109221 EUDAMED74895237109238 EUDAMED
- Basic UDI-DI
- 48952371514VT EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Surgical Mask by Kenpax International Limited — 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 | 48952371514VT | Class I | Active |
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Manufacturer
- Manufacturer
- Kenpax International Limited
- EUDAMED SRN
- HK-MF-000021152
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 875dac4f-9344-41d3-bdc1-128b3ed0622b 61 fields · synced Jul 13, 2026
- EUDAMED 56449a6f-f114-428d-917f-f21632acf700 61 fields · synced May 18, 2026