Identity
- Device Name
- Pulse Oximeter Sensors EUDAMED
- Model / Reference
- RSA002DA EUDAMEDRSA036DA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944290669971 EUDAMED
- Basic UDI-DI
- 69442906RSH4 EUDAMED
- Direct Marketing DI
- 06944290669971 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Malta 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 Sensors by Beijing Rongrui-Century Science & 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 | 69442906RSH4 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000015303
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 43f93249-15e2-4732-bb65-3173e6c0fe99 61 fields · synced Jun 19, 2026