← Back to catalogue
Disposable Endoscopy Adapter Set
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref FTL-VS-O-CRef FTL-VS-O-ARef FTL-VS-P-KRef FTL-VS-P-K1Ref FTL-VS-P-BRef FTL-VS-P-B1Ref FTL-VS-F700-DRef FTL-VS-P-ARef FTL-VS-O-DRef FTL-VS-P-CRef FTL-VS-P-C1Ref FTL-VS-F500/600-D
Identity
- Trade Name
- Disposable Endoscopy Adapter Set EUDAMED
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- FTL-VS-O-C EUDAMEDFTL-VS-O-A EUDAMEDFTL-VS-P-K EUDAMEDFTL-VS-P-K1 EUDAMEDFTL-VS-P-B EUDAMEDFTL-VS-P-B1 EUDAMEDFTL-VS-F700-D EUDAMEDFTL-VS-P-A EUDAMEDFTL-VS-O-D EUDAMEDFTL-VS-P-C EUDAMEDFTL-VS-P-C1 EUDAMEDFTL-VS-F500/600-D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936603216811 EUDAMED06936603216798 EUDAMED06936603216941 EUDAMED06936603216965 EUDAMED06936603216934 EUDAMED06936603216927 EUDAMED06936603217092 EUDAMED06936603216903 EUDAMED06936603216828 EUDAMED06936603216972 EUDAMED06936603216958 EUDAMED06936603217016 EUDAMED
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603216811 EUDAMED06936603216798 EUDAMED06936603216941 EUDAMED06936603216965 EUDAMED06936603216934 EUDAMED06936603216927 EUDAMED06936603217092 EUDAMED06936603216903 EUDAMED06936603216828 EUDAMED06936603216972 EUDAMED06936603216958 EUDAMED06936603217016 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Category: Gastro-urological guidewire, single-use
Disposable Endoscopy Adapter Set by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220210 | Class I | Active |
| 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 (13)
- EUDAMED 93d35aaa-ec09-4694-b08c-28ad28e6a8a8 61 fields · synced Aug 2, 2026
- EUDAMED 00d70bda-b105-4a33-aecd-d896396a92c5 61 fields · synced May 16, 2026
- EUDAMED 6f9906cc-d4fe-494a-a74c-d11ec7f5332e 61 fields · synced May 17, 2026
- EUDAMED 3a94b1b0-2ffd-4960-8e60-3c95e9fe4f46 61 fields · synced May 17, 2026
- EUDAMED 84618949-520e-4eb5-b3e0-85aa2e235dd2 61 fields · synced May 17, 2026
- EUDAMED ab1abcbb-046e-4b32-9539-1457f0a5aa0a 61 fields · synced May 18, 2026
- EUDAMED be1559dd-84ca-485c-8418-e5cf0353b062 61 fields · synced May 18, 2026
- EUDAMED ed2e6a22-cc48-4138-8f50-2305da7d987f 61 fields · synced May 18, 2026
- EUDAMED f25fbdb9-22dc-46b4-a976-69866eb9eb1c 61 fields · synced May 18, 2026
- EUDAMED abe462d2-4f56-4df8-8757-43411ed70e9e 61 fields · synced May 18, 2026
- EUDAMED 29e6aadb-9b6c-4271-b544-0ae5154235a9 61 fields · synced May 18, 2026
- EUDAMED 7b6c898a-de9f-4f11-9f8f-32e7a45ef8db 61 fields · synced May 18, 2026
- FDA 510(k) K220210 1 fields · synced May 18, 2026