Identity
- Trade Name
- SPO2 Sensors EUDAMED
- Device Name
- SPO2 Sensors EUDAMED
- Model / Reference
- A403S-01 EUDAMEDAF503-01X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927394501286 EUDAMED
- Basic UDI-DI
- 69273945SS01XK EUDAMED
- Direct Marketing DI
- 06927394501286 EUDAMED
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIb 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
SPO2 Sensors by Hunan Accurate Bio-Medical Technology Co., Ltd. — Class IIb — 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 | 69273945SS01XK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hunan Accurate Bio-Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012835
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cf628373-f173-40d3-b97a-67338dd78416 61 fields · synced Oct 8, 2026