Identity
- Device Name
- Reusable SpO2 Sensors EUDAMED
- Model / Reference
- XSPF3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974264560195 EUDAMED
- Basic UDI-DI
- 6974264560000000001NN EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Pulse oximeter probe, single-use
Reusable SpO2 Sensors by Xinkang Medical Instrument Co. , Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Pulse oximeter probe, single-use.
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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 | 6974264560000000001NN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Xinkang Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000011906
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fa3f8b99-e1c6-4e16-8a18-7920d34650e5 61 fields · synced May 23, 2026