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Wellue / Viatom
EUDAMEDClass IIa (EU MDR)
Ref PO5Model PO5, PO5-1, PO5-2, PO5-3
Identity
- Trade Name
- Wellue / Viatom EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- PO5, PO5-1, PO5-2, PO5-3 EUDAMEDPO5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440102205 EUDAMED
- Basic UDI-DI
- 69344401PO5ZN EUDAMED
- Direct Marketing DI
- 06934440102205 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Wellue / Viatom by Shenzhen Viatom Technology Co., Ltd. — Class IIa — 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 | 69344401PO5ZN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Viatom Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012182
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED b7c6fedf-a6f3-4881-91da-3b44e1125fa2 61 fields · synced Jun 15, 2026