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Digital Radiographic X-ray system
EUDAMEDClass IIb (EU MDR)
Ref INNOVISION-DXII
Identity
- Device Name
- Digital Radiographic X-ray system EUDAMED
- Model / Reference
- INNOVISION-DXII EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800001610206 EUDAMED
- Basic UDI-DI
- B-08800001610206 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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
Category: Stationary basic diagnostic x-ray system, digital
Digital Radiographic X-ray system by Dk Medical Systems 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-08800001610206 | Class IIb | Active |
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Manufacturer
- Manufacturer
- DK Medical Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000006102
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED e0afb0f3-269b-4036-a5e4-e85d8d02cfff 61 fields · synced Jun 18, 2026