Flexible Ureterorenoscopes
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Innovex FDA UDI
- Generic Name
- Flexible video ureterorenoscope, single-use FDA UDI
- Device Name
- Flexible Ureterorenoscopes EUDAMED
- Model / Reference
- US31D-12-US, US31D-12-EU and etc. EUDAMEDUS31E-12-EU EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970034210628 EUDAMEDFDA UDI
- Basic UDI-DI
- 697003421USWW EUDAMED
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020713 URETERORENOSCOPES EUDAMED
- GMDN Term
- Flexible video ureterorenoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
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
CE/MDR
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 (2)
- EUDAMED 73e16ebe-9475-401e-9000-0b8476135954 61 fields · synced Jul 17, 2026
- FDA UDI 05353bfa-de11-49ff-8a84-e5ad3bdc51bc 32 fields · synced May 30, 2026