Identity
- Trade Name
- Cytology Brush Gastroscope EUDAMEDCook FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- Colonoscope Cytology Brush, Cytology Brush Gastroscope EUDAMEDCytology Brush Gastroscope FDA UDI
- Model / Reference
- ECB-5-180-3-S EUDAMEDG22174 FDA UDI
- Description
- Cytology Brush Gastroscope FDA UDI
Identifiers
- Catalog Number
- ECB-5-180-3-S FDA UDI
- Primary DI / UDI-DI
- 00827002221741 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002WCM00000000031MK EUDAMED
- FDA Product Code
- FDX FDA UDI
- EMDN Code
- G03080301 GASTROINTESTINAL CYTOLOGY, BRUSHES EUDAMED
- GMDN Term
- Flexible endoscopic cytology brush, 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cytology Brush Gastroscope by Wilson-Cook Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0827002WCM00000000031MK | 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 (3)
- EUDAMED 3977f53f-1e7e-4598-ba87-08fca65b493b 61 fields · synced Oct 6, 2026
- FDA UDI b729a236-d78f-4902-9f66-8791003d50ae 36 fields · synced May 29, 2026
- EUDAMED 2842f0e2-cf2d-4b19-9e76-ca949aa748aa 61 fields · synced Jul 17, 2026