Identity
- Trade Name
- Medical Surgical Mask EUDAMED
- Device Name
- Medical Surgical Mask EUDAMED
- Model / Reference
- Type ⅡR EUDAMEDMDN 1201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973875400036 EUDAMED06973875400111 EUDAMED
- Basic UDI-DI
- 697387540GLMS01SY 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
Yes
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
Medical Surgical Mask by Changde Gelan Medical Device Co., Ltd. — 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 | 697387540GLMS01SY | Class I | Active |
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Manufacturer
- Manufacturer
- Changde Gelan Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000014273
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 9dc64e0a-7786-4712-a0cd-cbd4fd83e795 61 fields · synced Jul 31, 2026
- EUDAMED 7ed6c965-4a6b-4236-80a2-7e01717a8383 61 fields · synced May 19, 2026