Disposable Endoscopy Adapter Set
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Disposable Endoscopy Adapter Set EUDAMEDDisposable Endoscopy Adapter Sets FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMED
- Model / Reference
- FTL-VS-F700-C EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936603217085 EUDAMEDFDA UDI
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603217085 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
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 Endoscopy Adapter Set by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 (2)
- EUDAMED 129e5478-4287-4cdc-bf7c-13eb425df002 61 fields · synced Jul 11, 2026
- FDA UDI fc4be927-ec6a-4963-9ebf-0269394e9aaa 33 fields · synced May 30, 2026