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Flexible Choledochoscopes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CF132B-12-USModel CS50H-20EU, CS50H-20US and etcRef CS50H-20EU
Identity
- Trade Name
- Innovex FDA UDI
- Generic Name
- Flexible video choledochoscope, single-use FDA UDI
- Device Name
- Flexible Choledochoscopes EUDAMED
- Model / Reference
- CS50H-20EU, CS50H-20US and etc EUDAMEDCF132B-12-US EUDAMEDCS50H-20EU EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970034210215 EUDAMED06970034210550 EUDAMEDFDA UDI
- Basic UDI-DI
- 697003421CEUC EUDAMED
- 510(k) Number
- K231105 FDA UDI
- FDA Product Code
- FBN FDA UDI
- EMDN Code
- Z12020507 VIDEO CHOLEDOCOSCOPES EUDAMED
- GMDN Term
- Flexible video choledochoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- Not 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 Choledochoscopes 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 | 697003421CEUC | 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 (3)
- EUDAMED e51a39e8-a08e-4c7b-9082-d5afcd2c2a19 61 fields · synced Jul 9, 2026
- FDA UDI e8018dea-777c-478a-95bc-1e296ec4449a 34 fields · synced May 30, 2026
- EUDAMED 5262e562-9b5b-4e13-a10a-42a7149c8231 61 fields · synced Jul 9, 2026