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Soehendra Biliary Dilation Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref SBDC-11.5Ref SBDC-7E
Identity
- Trade Name
- Soehendra FDA UDI
- Generic Name
- Biliary drain FDA UDI
- Device Name
- SOEHENDRA BILIARY DILATION CATHETER EUDAMEDFDA UDI
- Model / Reference
- SBDC-11.5 EUDAMEDSBDC-7E EUDAMEDG50800 FDA UDIG22046 FDA UDI
- Description
- Soehendra Biliary Dilation Catheter FDA UDI
Identifiers
- Catalog Number
- SBDC-7E FDA UDISBDC-11.5 FDA UDI
- Primary DI / UDI-DI
- 00827002220461 EUDAMEDFDA UDI00827002508002 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002220461 EUDAMEDB-00827002508002 EUDAMED
- 510(k) Number
- K171548 FDA UDI
- FDA Product Code
- FGE FDA UDI
- EMDN Code
- G03010202 DIGESTIVE ENDOSCOPY, PROGRESSIVE FLEXIBLE DILATORS EUDAMED
- GMDN Term
- Biliary drain FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Soehendra Biliary Dilation Catheter by Wilson-Cook Medical, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00827002220461 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (4)
- EUDAMED 95ecbf85-4316-461b-aaed-06c134d5a72b 61 fields · synced Oct 6, 2026
- FDA UDI dc85e6cd-7001-4ea9-9dff-4904a39de4db 37 fields · synced May 26, 2026
- FDA UDI 760891ee-3058-4c27-8aad-c856a02e918b 37 fields · synced May 30, 2026
- EUDAMED 0df8288a-8001-4b87-9e26-524aab6964c1 61 fields · synced Aug 2, 2026