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Flexible Cystoscopes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CY50H-20USModel CY55H-24EU, CY55H-24US and etc.
Identity
- Trade Name
- Innovex FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- Flexible Cystoscopes EUDAMED
- Model / Reference
- CY55H-24EU, CY55H-24US and etc. EUDAMEDCY50H-20US EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970034210536 EUDAMEDFDA UDI
- Basic UDI-DI
- 697003421UBVU EUDAMED
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy 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 Cystoscopes by Shanghai Anqing Medical Instrument Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697003421UBVU | 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 66dc856f-efba-46d4-a974-89b4801bd35f 61 fields · synced Jul 23, 2026
- FDA UDI 0948466e-cb8e-40d8-91c1-e8fdee355e21 32 fields · synced May 30, 2026