Air/Water Valve
EUDAMEDClass I (EU MDR)
Identity
- Trade Name
- Air/Water Valve EUDAMED
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- AW-FJ-01 EUDAMEDFTL-VS-F500/600-I EUDAMEDAW-OLY-01 EUDAMEDFTL-VS-P-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936603217290 EUDAMED06936603217047 EUDAMED06936603217238 EUDAMED06936603216880 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603217290 EUDAMED06936603217047 EUDAMED06936603217238 EUDAMED06936603216880 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
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
Category: Gastro-urological guidewire, single-use
The Air/Water Valve is a disposable endoscopy adapter set designed for endoscopic procedures, offering a reliable and sterile connection between the endoscope and the patient's anatomy. Developed by Yangzhou Fartley Medical Instrument Technology Co., Ltd., this device is designed to provide a secure and effective interface for various endoscopic procedures.
Similar devices
Also classified as Gastro-urological guidewire, single-use.
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Tracer Metro — COOK INCORPORATED · Class II
- Sterile Hydro-Slide Guidewire — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Optimos™ Guidewire — Taewoong Medical · Class II
- Single Use Endoscope Valves set — Anrei Medical (HZ) CO., LTD. · Class I
- CeroFrict® — SML Med-Tech Solutions Limited · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69709008510147Y | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (4)
- EUDAMED b1c8cbcb-f530-4511-8582-3493d5839479 61 fields · synced Oct 6, 2026
- EUDAMED f3941ff3-ea93-4423-bd27-dcdc316cc9a3 61 fields · synced May 18, 2026
- EUDAMED 57055c59-f6af-44ec-8086-384c664c044e 61 fields · synced May 18, 2026
- EUDAMED 9faaf482-cf55-4ee5-8279-5d5928bcdb6b 61 fields · synced May 19, 2026