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Zen-X
EUDAMEDClass IIa (EU MDR)
Ref 701M0000, 701M0001Model Digital radiograpy sensors
by CEFLA s.c.
Identity
- Trade Name
- ZEN-X EUDAMED
- Model / Reference
- Digital radiograpy sensors EUDAMED701M0000, 701M0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837935667 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYINA001QX EUDAMED
- Direct Marketing DI
- 08033837935667 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
Zen-X 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 (2)
- EUDAMED 2a7d8ba5-f11e-486e-a373-21770949214f 61 fields · synced Jun 19, 2026
- EUDAMED 2a7d8ba5-f11e-486e-a373-21770949214f-1 61 fields · synced Jun 9, 2026