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Pulse Oximeter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref A310510(k) K200414Model A300, A310, A320, A330, A340, A310L, A340L
Identity
- Trade Name
- Pulse Oximeter EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- A310 EUDAMEDA300, A310, A320, A330, A340, A310L, A340L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947832500015 EUDAMED
- Basic UDI-DI
- B-06947832500015 EUDAMED69478325POXX20250305009T EUDAMED
- Direct Marketing DI
- 06947832500015 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDPoland 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 — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200414 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K190869 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06947832500015 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06947832500015 | 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 (3)
- EUDAMED db88c8f8-08b0-4def-aa7b-1f6fb28bf36d 85 fields · synced Jun 19, 2026
- EUDAMED 7e218b99-a174-4d8b-a129-7b264c49f481 61 fields · synced May 19, 2026
- FDA 510(k) K200414 1 fields · synced May 18, 2026