Identity
- Trade Name
- Pulse Oximeter EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- FS20A EUDAMEDFS10D1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927394500319 EUDAMED
- Basic UDI-DI
- 69273945PO01WA EUDAMED
- Direct Marketing DI
- 06927394500319 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
Our Pulse Oximeter device is a high-accuracy, reliable tool used for continuous monitoring of oxygen saturation levels in the blood. With advanced features like real-time data tracking and customizable user interfaces, it's ideal for healthcare professionals seeking precise patient care. Our device adheres to industry standards and regulatory requirements, ensuring seamless integration into any medical setting.
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 | 69273945PO01WA | Class IIa | 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 13e779bc-9b63-4d40-b311-809f1ac21c72 61 fields · synced Oct 7, 2026