Identity
- Trade Name
- R-RUI EUDAMED
- Device Name
- ECG Electrode Lead Wire &Accessories EUDAMED
- Model / Reference
- REK5008 EUDAMEDREK5008B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944290654267 EUDAMED
- Basic UDI-DI
- B-06944290654267 EUDAMED
- EMDN Code
- Z12030685 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
R-Rui by Beijing Rongrui-Century Science & Technology Co. , Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06944290654267 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000015303
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED aaa1b7a8-44aa-4468-956f-93a45549e8fc 61 fields · synced Oct 5, 2026