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Testeur d'étanchéité
EUDAMEDClass IIa (EU MDR)
Ref P1416B-1Model DPG-VRef P1416BModel DPG-I, DPG-III
Identity
- Trade Name
- Testeur d'étanchéité EUDAMED
- Device Name
- Video Ureterorenoscope EUDAMEDVideo Cystoscope EUDAMEDLeakage Tester EUDAMED
- Model / Reference
- DPG-V EUDAMEDP1416B-1 EUDAMEDDPG-I, DPG-III EUDAMEDP1416B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014618927 EUDAMED06947014621729 EUDAMED
- Basic UDI-DI
- 69470146EJ00287410GY EUDAMED69470146EJ00120610DA EUDAMED69470146RJ00175310TE EUDAMED
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMEDZ12020701 CYSTOSCOPES EUDAMEDZ12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
Testeur d'étanchéité by Hangzhou Hawk Optical Electronic Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- 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 | 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 (3)
- EUDAMED e1d4b988-d135-4357-a21f-e66918986cbe 61 fields · synced Aug 3, 2026
- EUDAMED a1d7cff0-4684-48fe-97a5-0d3fe6ff8081 61 fields · synced May 18, 2026
- EUDAMED 629a3146-12ad-4342-8f11-600b16274de9 61 fields · synced Aug 3, 2026