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X-Vs
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 701F0000, 701F0001Model Digital radiograpy sensors
by CEFLA s.c.
Identity
- Trade Name
- X-VS EUDAMEDNewTom FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- The X-VS sensor is intended to capture intraoral digital images when exposed to X-Rays. FDA UDI
- Model / Reference
- Digital radiograpy sensors EUDAMED701F0000, 701F0001 EUDAMEDX-VS FDA UDI
- Description
- The X-VS sensor is intended to capture intraoral digital images when exposed to X-Rays. FDA UDI
Identifiers
- Catalog Number
- XSENSONEWTOM FDA UDI
- Primary DI / UDI-DI
- 08033837931850 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYINA001QX EUDAMED
- Direct Marketing DI
- 08033837931850 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
X-Vs 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 180a448a-2e1e-40e2-a72e-19415ac711d0 61 fields · synced Jun 18, 2026
- FDA UDI a4dd1fee-692b-4a65-b87b-aabbc629a91e 37 fields · synced May 29, 2026
- EUDAMED 180a448a-2e1e-40e2-a72e-19415ac711d0-1 61 fields · synced Jun 10, 2026