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Disposable Electronic Flexible Ureteroscope
EUDAMEDClass IIa (EU MDR)
Ref UV-US100D-HModel UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H
Identity
- Device Name
- Disposable Electronic Flexible Ureteroscope EUDAMED
- Model / Reference
- UV-US100-H,UV-US110-H,UV-US120-H,UV-US130-H,UV-US100X-H,UV-US100D-H EUDAMEDUV-US100D-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973786290542 EUDAMED
- Basic UDI-DI
- 697378629UV8N EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Category: Flexible video ureteroscope, single-use
Disposable Electronic Flexible Ureteroscope by Shanghai SeeGen Photoelectric Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
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- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
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 | 697378629UV8N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015374
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 11349a7f-839a-4190-b9dd-e8a00356c24a 61 fields · synced Jun 19, 2026