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Disposable Electronic Flexible Choledochoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CHV-US100J-UModel CHV-US100J-U,CHV-US110J-U
Identity
- Trade Name
- Flexible Video-Choledochoscope FDA UDI
- Generic Name
- Flexible video choledochoscope, single-use FDA UDI
- Device Name
- Disposable Electronic Flexible Choledochoscope EUDAMED
- Model / Reference
- CHV-US100J-U,CHV-US110J-U EUDAMEDCHV-US100J-U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973786290030 EUDAMED06973786290641 FDA UDI
- Basic UDI-DI
- 697378629CHVXA EUDAMED
- 510(k) Number
- K222261 FDA UDI
- FDA Product Code
- FBN FDA UDI
- EMDN Code
- Z12020501 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
- France 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Electronic Flexible Choledochoscope by Shanghai SeeGen Photoelectric Technology 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 | 697378629CHVXA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015374
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED aea73e5e-9cf7-4a3e-93ed-193b30ff7840 61 fields · synced Jun 18, 2026
- FDA UDI ea6fab21-a16f-4409-bde0-6c4c70df7306 33 fields · synced May 30, 2026