Identity
- Trade Name
- EU-Scope FDA UDI
- Generic Name
- Flexible video ureteroscope, reusable FDA UDI
- Device Name
- 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
- Model / Reference
- US31B-12 FDA UDI
- 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
- 06970034210345 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Flexible video ureteroscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
EU-Scope by Shanghai Anqing Medical Instrument Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
Sources (1)
- FDA UDI f744e140-6da3-43dc-8164-624c282a1509 34 fields · synced May 30, 2026