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Lanhine
EUDAMEDClass I (EU MDR)
Ref 15603G 15703GRef 15806 PL 15806 15603JRef 15602F Model 15602F
Identity
- Trade Name
- Lanhine EUDAMED
- Device Name
- Medical face mask with shield or Visor EUDAMEDDisposable Mask EUDAMEDDisposable face mask(medical) EUDAMED
- Model / Reference
- 15603G 15703G EUDAMED15806 PL 15806 15603J EUDAMED15602F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971513680031 EUDAMED06971513680048 EUDAMED06971513680017 EUDAMED
- Basic UDI-DI
- 697151368MFMWSOV001WY EUDAMED697151368DM001BH EUDAMED697151368DFM001BQ EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Lanhine 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 | 697151368MFMWSOV001WY | 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 (3)
- EUDAMED b80e5b67-7575-43d0-9df3-ee4d1cb3f564 61 fields · synced Jul 26, 2026
- EUDAMED 8080438d-bdf3-40b6-a9f2-f347de89be15 61 fields · synced May 17, 2026
- EUDAMED 591d41ae-6ca4-47f3-b361-2a6319acaf29 61 fields · synced Jul 22, 2026