Identity
- Trade Name
- C50 EUDAMEDACTEON FDA UDI
- Generic Name
- Intraoral camera FDA UDI
- Device Name
- C50 EUDAMEDC50 camera and its single-use protective sheath is intended to visualize anatomical and pathological details that cannot be seen with the naked eye or with a mirror (thanks to its magnification) in DAYLIGHT or DAYLIGHT+ modes. These modes allow the dentist to show difference between "before" and "after" care, as well as pathology control and post-treatment. C50 does not provide a diagnostic. (Without fluorescence option) FDA UDI
- Model / Reference
- S_C50_0001 EUDAMEDS_C50_0002 EUDAMEDC50 - INTRAORAL CAMERA D FDA UDI
- Description
- C50 camera and its single-use protective sheath is intended to visualize anatomical and pathological details that cannot be seen with the naked eye or with a mirror (thanks to its magnification) in DAYLIGHT or DAYLIGHT+ modes. These modes allow the dentist to show difference between "before" and "after" care, as well as pathology control and post-treatment. C50 does not provide a diagnostic. (Without fluorescence option) FDA UDI
Identifiers
- Catalog Number
- S_C50_0002 FDA UDI
- Primary DI / UDI-DI
- 03760278267020 EUDAMEDFDA UDI
- Basic UDI-DI
- 801337602782D0006CZ EUDAMED
- Direct Marketing DI
- 03760278267037 EUDAMED
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Z11039010 PHOTO CAMERAS EUDAMED
- GMDN Term
- Intraoral camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
C50 by Sopro — 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 | 801337602782D0006CZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (2)
- EUDAMED 04116af2-e934-4630-800d-ea308452c693 61 fields · synced Jun 19, 2026
- FDA UDI 4453f5e5-c145-45db-93cb-89de556b32cc 35 fields · synced May 29, 2026