Identity
- Trade Name
- Endoscopic Camera System EUDAMED
- Device Name
- Endoscopic Camera System EUDAMED
- Model / Reference
- SV-300 EUDAMED90-071108-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973563040049 EUDAMED
- Basic UDI-DI
- 697356304SV-300J4 EUDAMED
- Direct Marketing DI
- 06973563040049 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 0ac5128b-7a67-4bc7-9bb9-07346bc6168b 61 fields · synced Jun 19, 2026