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C50
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref S_C50_0001Ref S_C50_0009
by Sopro
Identity
- Trade Name
- C50 EUDAMEDC50 INTRAORAL CAMERA US DAYL 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_0009 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_0009 FDA UDI
- Primary DI / UDI-DI
- 03760278266894 EUDAMED03760278267594 EUDAMEDFDA UDI
- Basic UDI-DI
- 801337602782D0006CZ EUDAMED
- Direct Marketing DI
- 03760278266153 EUDAMED03760278267037 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223470 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 801337602782D0006CZ | Class I | Active |
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Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (4)
- EUDAMED 38f43d3d-2409-49d3-9588-616edde9d518 61 fields · synced Jul 9, 2026
- EUDAMED 7d5786a4-9057-44e8-8b8c-413c3405e64e 61 fields · synced May 18, 2026
- FDA UDI 10c4ea00-1bf5-48fe-8f23-267766d24c6f 35 fields · synced May 29, 2026
- FDA 510(k) K223470 1 fields · synced May 18, 2026