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WiBU PflegePlus GmbH
EUDAMEDClass I (EU MDR)
Ref 809553Model 15603F,15603J,15806J,15703F, 15603P,15703P, 15603G,15703G
Identity
- Trade Name
- WiBU PflegePlus GmbH EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- 15603F,15603J,15806J,15703F, 15603P,15703P, 15603G,15703G EUDAMED809553 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971513688440 EUDAMED
- Basic UDI-DI
- 69715136815603FTJ 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
WiBU PflegePlus GmbH 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 | 69715136815603FTJ | 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 ebeb92f4-6a3d-4c33-8b58-6b460f90bfdf 61 fields · synced Jun 17, 2026