← Back to catalogue
Portable Dental x-ray system
EUDAMEDClass IIb (EU MDR)
Ref IFU-10Model DX-7020s
by Dexcowin
Identity
- Device Name
- Portable Dental x-ray system EUDAMED
- Model / Reference
- DX-7020s EUDAMEDIFU-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800000500164 EUDAMED
- Basic UDI-DI
- B-08800000500164 EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Portable Dental x-ray system by Dexcowin — Class IIb — 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-08800000500164 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dexcowin
- EUDAMED SRN
- KR-MF-000032389
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (1)
- EUDAMED ebf00fb9-94d3-4262-9b84-35ad518a232d 61 fields · synced May 23, 2026