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Flexible Ureterorenoscopes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref US33G-17-USModel US31D-12-US, US31D-12-EU and etc.Ref US27G-12-USRef US38G-20-USRef US27J-12-EURef US33J-17-EURef US38J-20-EURef US27G-12-EURef US33G-17-EURef US31C-12-EURef US27H-12-USRef US31B-12Ref US27L-12-USRef US23K-10-EURef US27J-12-USRef US23K-10-USRef US27L-12-EU
Identity
- Trade Name
- EU－Scope FDA UDI
- Generic Name
- Flexible video ureteroscope, reusable FDA UDI
- Device Name
- Flexible Ureterorenoscopes EUDAMEDFlexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed DOSTM video processor approved by SHANGHAI ANQING. FDA UDI
- Model / Reference
- US31D-12-US, US31D-12-EU and etc. EUDAMEDUS33G-17-US EUDAMEDUS27G-12-US EUDAMEDUS38G-20-US EUDAMEDUS27J-12-EU EUDAMEDUS33J-17-EU EUDAMEDUS38J-20-EU EUDAMEDUS27G-12-EU EUDAMEDUS33G-17-EU EUDAMEDUS31C-12-EU EUDAMEDUS27H-12-US EUDAMEDUS31B-12 EUDAMEDFDA UDIUS27L-12-US EUDAMEDUS23K-10-EU EUDAMEDUS27J-12-US EUDAMEDUS23K-10-US EUDAMEDUS27L-12-EU EUDAMED
- Description
- Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed DOSTM video processor approved by SHANGHAI ANQING. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970034211199 EUDAMED06970034211212 EUDAMED06970034211175 EUDAMED06970034211656 EUDAMED06970034211670 EUDAMED06970034211694 EUDAMED06970034211205 EUDAMED06970034211182 EUDAMED06970034210376 EUDAMED06970034211311 EUDAMED06970034210130 EUDAMEDFDA UDI06970034212301 EUDAMED06970034211953 EUDAMED06970034211663 EUDAMED06970034211960 EUDAMED06970034212295 EUDAMED
- Basic UDI-DI
- 697003421USWW EUDAMED
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
- GMDN Term
- Flexible video ureteroscope, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy EUDAMEDSpain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video ureteroscope, single-use
Flexible Ureterorenoscopes by Shanghai Anqing Medical Instrument Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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
- WiScope® — OTU MEDICAL INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697003421USWW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000008487
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (17)
- EUDAMED bbfe0a42-bf43-45cb-8987-3ea3dbb0a6ee 61 fields · synced Oct 6, 2026
- EUDAMED 0a53ecdb-1e52-4e19-a7e6-887f3433f55b 61 fields · synced May 11, 2026
- EUDAMED ac7223ef-8223-4213-b555-e6aca192e0fd 61 fields · synced May 16, 2026
- EUDAMED 00ab0c6f-3a22-4d24-ada2-20518f4a4226 61 fields · synced May 16, 2026
- EUDAMED e0399546-3853-42e6-b277-c71331595441 61 fields · synced May 17, 2026
- EUDAMED f307e710-d419-4979-ba2d-2a3327e51d35 61 fields · synced May 17, 2026
- EUDAMED f18dca47-2305-4f14-8b67-4d953a187f71 61 fields · synced May 17, 2026
- EUDAMED a1a3fba6-ba87-4388-b379-1b7de58d0290 61 fields · synced May 17, 2026
- EUDAMED f87708e6-104f-4550-a585-2c98aa6c8263 61 fields · synced May 18, 2026
- EUDAMED 1b6f7fd3-1695-497d-bc38-c5db083a8006 61 fields · synced May 18, 2026
- FDA UDI 2eff9667-f5b2-4e68-9ec8-c402f580aaae 33 fields · synced May 29, 2026
- EUDAMED 0622f403-c6bd-460d-af6b-fdb90b514440 61 fields · synced Jul 9, 2026
- EUDAMED e606dac9-8e1c-4bba-acd0-601d89781f03 61 fields · synced Jul 10, 2026
- EUDAMED 7988885f-78ae-488e-8d96-96f049dffebf 61 fields · synced Jul 12, 2026
- EUDAMED c564a64f-693a-4bdf-b834-6f5f5fcd2872 61 fields · synced Jul 28, 2026
- EUDAMED 7b34794b-2823-49b4-88c0-2b138761fd56 61 fields · synced Jul 31, 2026
- EUDAMED 50e7da72-71ea-43b6-a811-e2dfc1de58b9 61 fields · synced Aug 4, 2026