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hy-scan
EUDAMEDClass IIa (EU MDR)
Ref 95510216; 703I0000Model Devices for recording X-ray imaging for intra oral images
by CEFLA s.c.
Identity
- Trade Name
- hy-scan EUDAMED
- Device Name
- hy-scan EUDAMED
- Model / Reference
- Devices for recording X-ray imaging for intra oral images EUDAMED95510216; 703I0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837937272 EUDAMED
- Basic UDI-DI
- B-08033837937272 EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
hy-scan by CEFLA s.c. — Class IIa — 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-08033837937272 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (2)
- EUDAMED d3ec6ba6-32a9-41bd-8d7b-e2d0bf39fe18-1 61 fields · synced Jul 10, 2026
- EUDAMED d3ec6ba6-32a9-41bd-8d7b-e2d0bf39fe18-2 61 fields · synced Jul 10, 2026