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Flexible Choledochoscope
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref CD136A-12510(k) K231105
Identity
- Device Name
- Flexible Choledochoscope EUDAMED
- Model / Reference
- CD136A-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970034210598 EUDAMED
- Basic UDI-DI
- 697003421CDUA EUDAMED
- 510(k) Number
- K231105 FDA 510(k)
- FDA Product Code
- FBN FDA 510(k)
- EMDN Code
- Z12020507 VIDEO CHOLEDOCOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- Austria EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Flexible Choledochoscope by Shanghai Anqing Medical Instrument Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231105 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697003421CDUA | Class IIa | Active |
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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 79a9a6f5-1de9-41f4-9f9b-6f4cbc458db6 61 fields · synced Aug 3, 2026
- FDA 510(k) K231105 24 fields · synced May 18, 2026