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NewTom DCiS WL
EUDAMEDClass IIa (EU MDR)
Ref 701FW001, 701FW051Model Digital radiograpy sensors
by CEFLA s.c.
Identity
- Trade Name
- NewTom DCiS WL EUDAMED
- Model / Reference
- Digital radiograpy sensors EUDAMED701FW001, 701FW051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837935988 EUDAMED
- Basic UDI-DI
- 803383793IMXRAYINA001QX EUDAMED
- Direct Marketing DI
- 08033837935988 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
NewTom DCiS WL 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 c9201663-bbed-43b4-a2ec-a9dd31a35eb7 61 fields · synced Jul 17, 2026
- EUDAMED c9201663-bbed-43b4-a2ec-a9dd31a35eb7-1 61 fields · synced Jun 10, 2026