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X-Vs E
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref "701X0001, 701X0002, 701XC000 "Model Digital radiograpy sensors
by CEFLA s.c.
Identity
- Trade Name
- X-VS E EUDAMEDCastellini FDA UDI
- Generic Name
- Dental digital imaging sensor, intraoral FDA UDI
- Device Name
- The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. FDA UDI
- Model / Reference
- Digital radiograpy sensors EUDAMED"701X0001, 701X0002, 701XC000 " EUDAMEDX-VS E FDA UDI
- Description
- The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033837936855 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMXRAYINA001QX EUDAMED
- Direct Marketing DI
- 08033837936855 EUDAMED
- 510(k) Number
- K210312 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 E 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 d975515a-77dc-4360-88f8-470f620a5ccc 61 fields · synced Jun 19, 2026
- FDA UDI 7a1ee545-49bd-42cb-a86c-78f41e23f932 35 fields · synced May 25, 2026
- EUDAMED d975515a-77dc-4360-88f8-470f620a5ccc-1 61 fields · synced Jun 10, 2026