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Single-use Choledochoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CH-M52Model CH-M52,CH-M52H
Identity
- Trade Name
- Single-Use Choledochoscope FDA UDI
- Generic Name
- Flexible video choledochoscope, single-use FDA UDI
- Device Name
- Single-use Choledochoscope EUDAMED
- Model / Reference
- CH-M52,CH-M52H EUDAMEDCH-M52 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462541264 EUDAMED06970462546313 FDA UDI
- Basic UDI-DI
- 69704625420197Y EUDAMED
- 510(k) Number
- K231497 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
- Germany 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single-use Choledochoscope by Shenzhen HugeMed Medical Technical Development 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 | 69704625420197Y | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 90093a2e-15bc-4da2-84d0-15ec002e244c 61 fields · synced May 31, 2026
- FDA UDI c8c8ac07-7b45-4618-8845-ecce22ab993c 33 fields · synced May 29, 2026