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Cytomax Ii Double Lumen Cytology Brush
EUDAMEDFDA UDIClass I (EU MDR)
Ref DLB-35-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-S EUDAMEDG24741 FDA UDI
- Description
- Cytomax II Double Lumen Cytology Brush FDA UDI
Identifiers
- Catalog Number
- DLB-35-S FDA UDI
- Primary DI / UDI-DI
- 00827002247413 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002247413 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-00827002247413 | 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 a51b3c7a-312e-48b2-a118-9261a8cd863a 61 fields · synced Oct 6, 2026
- FDA UDI 5a2ffa09-f7ad-49c9-980c-b1ec0b9c7294 36 fields · synced May 30, 2026