← Back to catalogue
Cytomax Ii Double Lumen Cytology Brush
EUDAMEDFDA UDIClass I (EU MDR)
Ref DLB-35-3.5-S
Identity
- Trade Name
- CytoMax II FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- CYTOMAX II DOUBLE LUMEN CYTOLOGY BRUSH EUDAMEDFDA UDI
- Model / Reference
- DLB-35-3.5-S EUDAMEDG22675 FDA UDI
- Description
- Cytomax II Double Lumen Cytology Brush FDA UDI
Identifiers
- Catalog Number
- DLB-35-3.5-S FDA UDI
- Primary DI / UDI-DI
- 00827002226753 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002226753 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
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
Cytomax Ii Double Lumen Cytology Brush 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-00827002226753 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (3)
- EUDAMED 096c1cec-12cb-48de-b070-c6520490783d 61 fields · synced Oct 7, 2026
- FDA UDI 12974fb7-b260-4291-b7e8-1f6c7bc49805 36 fields · synced May 30, 2026
- EUDAMED c01e951b-8e4b-4d4d-bcbb-68df54d7ba3c 61 fields · synced Oct 7, 2026