Identity
- Device Name
- SURGICAL FACE MASK EUDAMED
- Model / Reference
- L EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260666483272 EUDAMED04260666483265 EUDAMED04260666483258 EUDAMED04260666483302 EUDAMED04260666483289 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
EUDAMEDEUDAMED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Lanhine Medical Products Ltd.
- EUDAMED SRN
- CN-MF-000008843
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 52325ab9-ceb3-4690-a4c6-89ae1b79d8b1 61 fields · synced Jul 30, 2026
- EUDAMED 33045812-c688-486d-a53a-cf5f041a80ff 61 fields · synced May 17, 2026
- EUDAMED 95eb953a-6a10-465b-a3b8-1e62cee99d5b 61 fields · synced May 17, 2026
- EUDAMED 08993366-82d1-4c6f-92d2-838cd642952a 61 fields · synced May 18, 2026
- EUDAMED 1713e5da-4e1a-4b68-993a-6b3fa5d0b6db 61 fields · synced May 19, 2026