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X-ViSUS DCiS
EUDAMEDClass IIa (EU MDR)
Ref 701BW011Model Digital radiograpy sensorsRef 701BW001, 701BW051
by CEFLA s.c.
Identity
- Trade Name
- X-ViSUS DCiS EUDAMED
- Model / Reference
- Digital radiograpy sensors EUDAMED701BW011 EUDAMED701BW001, 701BW051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837935865 EUDAMED08033837935858 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYINA001QX EUDAMED
- Direct Marketing DI
- 08033837935865 EUDAMED08033837935858 EUDAMED
- EMDN Code
- Z11030480 INSTRUMENTS FOR ENDORAL RADIOLOGY - CONSUMABLES 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
X-ViSUS DCiS by CEFLA s.c. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYINA001QX | Class IIa | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (3)
- EUDAMED b3cdcfbd-3080-4dec-bd82-f491d2b5392f 61 fields · synced Jul 26, 2026
- EUDAMED e21a9552-17b7-4c9a-ad5d-e66d3927bdec 61 fields · synced May 19, 2026
- EUDAMED e21a9552-17b7-4c9a-ad5d-e66d3927bdec-1 61 fields · synced Jun 10, 2026