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Soprocare
EUDAMEDFDA UDIClass I (EU MDR)
Ref S_950_0004Model S_C50_0001
by Sopro
Identity
- Trade Name
- SOPROCARE EUDAMEDACTEON FDA UDI
- Generic Name
- Diagnostic-imaging multiformat camera FDA UDI
- Device Name
- C50 EUDAMEDThe SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror (thanks to its magnification). In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing). This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition. FDA UDI
- Model / Reference
- S_C50_0001 EUDAMEDS_950_0004 EUDAMEDCAMERA S950 NTSC SOPROCARE WS FDA UDI
- Description
- The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror (thanks to its magnification). In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing). This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition. FDA UDI
Identifiers
- Catalog Number
- S_950_0004 FDA UDI
- Primary DI / UDI-DI
- 03760278260984 EUDAMEDFDA UDI
- Basic UDI-DI
- 801337602782D0006CZ EUDAMED
- Direct Marketing DI
- 03760278260281 EUDAMED
- FDA Product Code
- NYH FDA UDI
- EMDN Code
- Z11039010 PHOTO CAMERAS EUDAMED
- GMDN Term
- Diagnostic-imaging multiformat camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1740 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Soprocare 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 d3c8663f-d24e-4182-8a28-fb2deb2e33d8 61 fields · synced Jul 10, 2026
- FDA UDI e1da6c59-b359-4366-93c0-c119179bfa7b 35 fields · synced May 30, 2026