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C-U2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 70220000, 76100400Model Intraoral camera
by CEFLA s.c.
Identity
- Trade Name
- C-U2 EUDAMEDmyray FDA UDI
- Generic Name
- Intraoral camera FDA UDI
- Device Name
- The device is a camera system specifically intended to examine the oral cavity. This system is designed to allow the dentist to more efficiently show and explain to patients all oral conditions and reasons for planned treatment. FDA UDI
- Model / Reference
- Intraoral camera EUDAMED70220000, 76100400 EUDAMEDC-U2 FDA UDI
- Description
- The device is a camera system specifically intended to examine the oral cavity. This system is designed to allow the dentist to more efficiently show and explain to patients all oral conditions and reasons for planned treatment. FDA UDI
Identifiers
- Catalog Number
- 70220000 FDA UDI
- Primary DI / UDI-DI
- 08033837930174 EUDAMEDFDA UDI
- Basic UDI-DI
- 803383793IMINTRCA10015U EUDAMED
- Direct Marketing DI
- 08033837930174 EUDAMED
- 510(k) Number
- K062897 FDA UDI
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Intraoral camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 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
C-U2 by CEFLA s.c. — Class I — 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 | 803383793IMINTRCA10015U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (3)
- EUDAMED 0f76016b-71a0-4960-a028-8d1ad6059fb9 61 fields · synced Aug 3, 2026
- FDA UDI 68d8b7dc-a798-4863-8200-344c9c6b7bd1 37 fields · synced May 30, 2026
- EUDAMED 0f76016b-71a0-4960-a028-8d1ad6059fb9-1 61 fields · synced Jun 9, 2026