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Pulse Oximeter
EUDAMEDClass IIa (EU MDR)
Ref A300Model A300, A310, A320, A330, A340, A310L, A340L
Identity
- Trade Name
- Pulse Oximeter EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- A300, A310, A320, A330, A340, A310L, A340L EUDAMEDA300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947832502453 EUDAMED
- Basic UDI-DI
- 69478325POXX20250305009T EUDAMED
- Direct Marketing DI
- 06947832502453 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Pulse Oximeter by Shenzhen Aeon 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 | 69478325POXX20250305009T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Aeon Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012690
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c841b627-029c-4026-b85a-bd81b22e53da 61 fields · synced Jun 18, 2026