Identity
- Trade Name
- Disposable Biopsy Valve EUDAMEDFDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- FTL-BV-F-EO EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936603217139 EUDAMEDFDA UDI
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603217139 EUDAMED
- 510(k) Number
- K220210 FDA UDI
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope working-channel valve, 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
No
FDA UDI
Category: Gastro-urological guidewire, single-use
Disposable Biopsy Valve by Yangzhou Fartley Medical Instrument Technology Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Gastro-urological guidewire, single-use.
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- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Optimos™ Guidewire — Taewoong Medical · Class II
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 | 69709008510147Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED ab0c7e72-0cbe-4c61-80c7-d1a7e724f7bf 61 fields · synced Jun 8, 2026
- FDA UDI 127a3f9a-56e7-4616-a0de-03bbc80a17aa 33 fields · synced May 30, 2026