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Zen-X
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 701A0000, 701A0001Model Digital radiograpy sensors
by CEFLA s.c.
Identity
- Trade Name
- ZEN-X EUDAMEDmyray FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- The ZEN-X sensor is intended to capture intraoral digital images when exposed to X-Rays. FDA UDI
- Model / Reference
- Digital radiograpy sensors EUDAMED701A0000, 701A0001 EUDAMEDZEN-X FDA UDI
- Description
- The ZEN-X sensor is intended to capture intraoral digital images when exposed to X-Rays. FDA UDI
Identifiers
- Catalog Number
- XZENX17 FDA UDI
- Primary DI / UDI-DI
- 08033837930327 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYINA001QX EUDAMED
- Direct Marketing DI
- 08033837930327 EUDAMED
- 510(k) Number
- K100960 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11030480 INSTRUMENTS FOR ENDORAL RADIOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Dental digital imaging sensor, intraoral FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Zen-X by CEFLA s.c. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793IMXRAYINA001QX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (3)
- EUDAMED 40374971-1881-4c6a-8920-9f86cf4214c5 61 fields · synced Jun 19, 2026
- FDA UDI a22a7cfb-5f91-4c44-aea1-1d213b76c341 37 fields · synced May 30, 2026
- EUDAMED 40374971-1881-4c6a-8920-9f86cf4214c5-1 61 fields · synced Jun 10, 2026