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Endoscopic Camera System
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 90-071107-00Model SV-300510(k) K250204
Identity
- Trade Name
- Endoscopic Camera System EUDAMED
- Device Name
- Endoscopic Camera System EUDAMED
- Model / Reference
- SV-300 EUDAMED90-071107-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973563040032 EUDAMED
- Basic UDI-DI
- 697356304SV-300J4 EUDAMED
- Direct Marketing DI
- 06973563040032 EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Endoscopic Camera System by Shenzhen Sophway Technology Co., Ltd. — 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 | K250204 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697356304SV-300J4 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sophway Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027700
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED d11d0e02-4f02-45b7-9cf1-fa5ea22a581f 85 fields · synced Jun 19, 2026
- FDA 510(k) K250204 1 fields · synced May 18, 2026