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Single Cytology Brush
EUDAMEDClass IIa (EU MDR)
Ref SCB-US-18-04-10-120Model FTL-BC-18-40-105-S
Identity
- Trade Name
- Single Cytology Brush EUDAMED
- Device Name
- Disposable Cytology Brush EUDAMED
- Model / Reference
- FTL-BC-18-40-105-S EUDAMEDSCB-US-18-04-10-120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936603214848 EUDAMED
- Basic UDI-DI
- 697090085102483 EUDAMED
- Direct Marketing DI
- 06936603214848 EUDAMED
- EMDN Code
- G03080301 GASTROINTESTINAL CYTOLOGY, BRUSHES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Single Cytology Brush by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697090085102483 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 70c27397-3230-4657-8674-605bbf739798 61 fields · synced Jun 18, 2026