PENTAX Medical Single Use Valve 2 pcs set
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- PENTAX Medical Single Use Valve 2 pcs set EUDAMEDDisposable Endoscopy Adapter Sets FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Disposable Endoscopy Adapter Sets EUDAMEDPENTAX 90i: Air/Water Valve + Suction Valve FDA UDI
- Model / Reference
- 115292 EUDAMEDFTL-VS-P-A FDA UDI
- Description
- PENTAX 90i: Air/Water Valve + Suction Valve FDA UDI
Identifiers
- Catalog Number
- 115292 FDA UDI
- Primary DI / UDI-DI
- 06936603216460 EUDAMEDFDA UDI
- Basic UDI-DI
- 69709008510147Y EUDAMED
- Direct Marketing DI
- 06936603216460 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
PENTAX Medical Single Use Valve 2 pcs set by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA…
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222980 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69709008510147Y | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (3)
- EUDAMED 86cb3dfd-b0f0-4f67-b9e6-777a89b4bf6d 61 fields · synced Oct 6, 2026
- FDA UDI 45926d4c-fc10-4393-bf0f-f6632bb98807 35 fields · synced May 30, 2026
- FDA 510(k) K222980 1 fields · synced May 18, 2026