Identity
- Trade Name
- Single use flexible choledochoscope EUDAMED
- Device Name
- Single use flexible choledochoscope EUDAMED
- Model / Reference
- CH-D1,CH-F1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355350963 EUDAMED
- Basic UDI-DI
- 697135535022288 EUDAMED
- EMDN Code
- Z12020507 VIDEO CHOLEDOCOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
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
Single use flexible choledochoscope by Shenzhen Besdata Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697135535022288 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED c52e5d88-a865-4e04-931c-b838be69b52c 61 fields · synced Jun 19, 2026
- EUDAMED c52e5d88-a865-4e04-931c-b838be69b52c-1 61 fields · synced Jun 9, 2026