Identity
- Trade Name
- Huibregtse Katon FDA UDI
- Generic Name
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
- Device Name
- HUIBREGTSE-KATON ERCP CATHETER EUDAMEDHuibregtse Katon ERCP Catheter FDA UDI
- Model / Reference
- ERCP-1-HKB-D EUDAMEDG57289 FDA UDI
- Description
- Huibregtse Katon ERCP Catheter FDA UDI
Identifiers
- Catalog Number
- ERCP-1-HKB-D FDA UDI
- Primary DI / UDI-DI
- 00827002572898 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002572898 EUDAMED
- 510(k) Number
- K171989 FDA UDI
- FDA Product Code
- ODD FDA UDI
- EMDN Code
- G0304010199 ERCP CANNULAS, SINGLE-LUMEN - OTHER EUDAMED
- GMDN Term
- ERCP catheter, non-balloon, non-electrical, single-use FDA UDI
Classification
- Device Class
- Class I 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
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
Huibregtse-Katon Ercp 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-00827002572898 | 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 (2)
- EUDAMED e7d72d25-a8c4-4d3c-a86a-7bafab1cf08c 61 fields · synced Oct 6, 2026
- FDA UDI 46861d1c-a71a-4ed6-bef5-957719e84e44 37 fields · synced May 29, 2026