Identity
- Device Name
- SURGICAL FACE MASK EUDAMED
- Model / Reference
- L EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260666483296 EUDAMED
- Basic UDI-DI
- 42606664MASK01FE 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 Face Mask by Zhejiang Lanhine Medical Products 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 | 42606664MASK01FE | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Lanhine Medical Products Ltd.
- EUDAMED SRN
- CN-MF-000008843
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6dd0bc3d-710f-4d78-bb85-709ae9583c0f 61 fields · synced Jun 18, 2026