Disposable Biopsy Valve
EUDAMEDFDA UDIClass I (EU MDR)
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-O-EO EUDAMEDFDA UDIBM-BV-O EUDAMEDFTL-BV-P-0-EO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970900850934 EUDAMEDFDA UDI06936603200414 EUDAMED06936603217160 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06970900850934 EUDAMED06936603200414 EUDAMED06936603217160 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 EUDAMEDBelgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
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.
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
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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
CE/MDR
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 (4)
- EUDAMED fbd23c7c-d816-40e8-bdf1-c340256b39c8 61 fields · synced Jul 31, 2026
- EUDAMED ecef028f-7497-43fc-8631-56b44502ceb9 61 fields · synced May 17, 2026
- EUDAMED fc70fa9a-2ef7-4abd-aac7-a16a36503263 61 fields · synced May 19, 2026
- FDA UDI 4e93342d-c7a7-47ac-9a93-3bc91f19580f 33 fields · synced May 30, 2026