Identity
- Trade Name
- Auxiliary Jet Adapter EUDAMEDWater Jet Adapter FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- FTL-VS-P-WJ EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936603216897 EUDAMEDFDA UDI
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603216897 EUDAMED
- 510(k) Number
- K220210 FDA UDI
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Endoscope channel support kit 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
Auxiliary Jet Adapter by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Gastro-urological guidewire, single-use.
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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 dd10ea04-dfc7-4670-b984-d5f28d240058 61 fields · synced Oct 7, 2026
- FDA UDI 3218110d-881c-47d0-9a2c-a9faa56c9270 33 fields · synced May 30, 2026