Identity
- Trade Name
- Urétéroscope souple F6.5 EUDAMED
- Device Name
- Video Ureterorenoscope EUDAMED
- Model / Reference
- DPG-V EUDAMEDDR025670 3E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014618873 EUDAMED
- Basic UDI-DI
- 69470146EJ00287410GY EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Urétéroscope souple F6.5 by Hangzhou Hawk Optical Electronic Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Flexible video ureteroscope, single-use.
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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 | 69470146EJ00287410GY | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED bb3c0f6b-a606-48a9-8a09-f69e33095c19 61 fields · synced Jun 19, 2026