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Single-use Video Transforaminal Endoscope
EUDAMEDClass IIa (EU MDR)
Ref SSV-1015LModel SSV-5823、SSV-5823L、SSV-6315、SSV-6323、 SSV-6323L、SSV-7023、SSV-7315、SSV-7315L、SSV-7323、SSV-1015、SSV-1015L
Identity
- Trade Name
- Single-use Video Transforaminal Endoscope EUDAMED
- Device Name
- Single-use Video Transforaminal Endoscope EUDAMED
- Model / Reference
- SSV-5823、SSV-5823L、SSV-6315、SSV-6323、 SSV-6323L、SSV-7023、SSV-7315、SSV-7315L、SSV-7323、SSV-1015、SSV-1015L EUDAMEDSSV-1015L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381252071 EUDAMED
- Basic UDI-DI
- 697138125013A8A EUDAMED
- Direct Marketing DI
- 06971381252071 EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Single-use Video Transforaminal Endoscope by Scivita Medical Technology Co., Ltd. — Class IIa — 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 | 697138125013A8A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3c4c416c-3a8f-421f-838a-a64f838932a8 61 fields · synced Jun 18, 2026