Identity
- Trade Name
- RUI EUDAMED
- Device Name
- Pulse Oximeter Sensors EUDAMED
- Model / Reference
- RSJ001DA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16944290665550 EUDAMED
- Basic UDI-DI
- B-16944290665550 EUDAMED
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulse oximeter probe, single-use
Rui by Beijing Rongrui-Century Science & Technology Co. , Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16944290665550 | 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 f663ea2e-4986-4331-90d7-d131582f0e33 61 fields · synced Jun 19, 2026