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Babytone
EUDAMEDClass IIa (EU MDR)
Ref PO5Model PO5, PO5-1, PO5-2, PO5-3 Ref PO5-2
Identity
- Trade Name
- Babytone EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- PO5, PO5-1, PO5-2, PO5-3 EUDAMEDPO5 EUDAMEDPO5-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934440101956 EUDAMED06934440102106 EUDAMED
- Basic UDI-DI
- 69344401PO5ZN EUDAMED
- Direct Marketing DI
- 06934440101956 EUDAMED06934440102106 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
Babytone 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 (2)
- EUDAMED 49d7a6b1-84fb-44fb-9ce6-c123f2656a89 61 fields · synced Jul 17, 2026
- EUDAMED b0d37b6d-14ed-42af-b551-b12d083cb176 61 fields · synced May 17, 2026