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Flexible Ureterorenoscopes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref US31D-12-EUModel US31D-12-US, US31D-12-EU and etc.
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. EUDAMEDUS31D-12-EU EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970034210383 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
- Romania 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Flexible Ureterorenoscopes by Shanghai Anqing Medical Instrument Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 (2)
- EUDAMED b4ef858a-eb3c-4976-9f8b-49ea07db96d4 61 fields · synced Jun 20, 2026
- FDA UDI bc150191-5191-436f-acdf-df38091dd7f9 32 fields · synced May 30, 2026