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Diagnostic X-ray Generaor with Tube Assembly
EUDAMEDClass IIb (EU MDR)
Ref 2001Model RayNova Rph
Identity
- Device Name
- Diagnostic X-ray Generaor with Tube Assembly EUDAMED
- Model / Reference
- RayNova Rph EUDAMED2001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975312910603 EUDAMED
- Basic UDI-DI
- B-06975312910603 EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS 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
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
Diagnostic X-ray Generaor with Tube Assembly by Kuanteng (Liaoning) Medical Devices Co., Ltd. — Class IIb — MDD — listed in EUDAMED
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-06975312910603 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Kuanteng (Liaoning) Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000010538
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b2b83797-cf96-40cb-b395-5d055cfee13d 61 fields · synced Jun 18, 2026