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Soprocare
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref S_950_0011Model S_C50_0001
by Sopro
Identity
- Trade Name
- SOPROCARE EUDAMED
- Device Name
- C50 EUDAMED
- Model / Reference
- S_C50_0001 EUDAMEDS_950_0011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278262827 EUDAMED
- Basic UDI-DI
- 801337602782D0006CZ EUDAMED
- Direct Marketing DI
- 03760278260281 EUDAMED
- EMDN Code
- Z11039010 PHOTO CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Soprocare by Sopro — Class I — FDA_510K, MDR — listed in EUDAMED, 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 | K121685 | 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 (2)
- EUDAMED 6f64cb77-7d47-4667-8821-2518272f9867 61 fields · synced Jun 19, 2026
- FDA 510(k) K121685 1 fields · synced May 18, 2026