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Disposable Endoscope Valves Kit
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref SG-DVK-FJ-700EModel SG-DVK-OL-200,SG-DVK-OL-200E,SG-DVK-OL-200W,SG-DVK-FJ-700,SG-DVK-FJ-700E,SG-DVK-FJ-700W,SG-DVK-PT-I1090,SG-DVK-PT-I1090E,SG-DVK-PT-I1090W,SG-DVK-PT-NP1,SG-DVK-PT-NP1E,SG-DVK-PT-NP1W
Identity
- Trade Name
- Disposable Endoscope Valves Kit FDA UDI
- Generic Name
- Endoscope air/water valve, single-use FDA UDI
- Device Name
- Disposable Endoscope Valves Kit EUDAMED
- Model / Reference
- SG-DVK-OL-200,SG-DVK-OL-200E,SG-DVK-OL-200W,SG-DVK-FJ-700,SG-DVK-FJ-700E,SG-DVK-FJ-700W,SG-DVK-PT-I1090,SG-DVK-PT-I1090E,SG-DVK-PT-I1090W,SG-DVK-PT-NP1,SG-DVK-PT-NP1E,SG-DVK-PT-NP1W EUDAMEDSG-DVK-FJ-700E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973786290375 EUDAMEDFDA UDI
- Basic UDI-DI
- 697378629VK83 EUDAMED
- 510(k) Number
- K222499 FDA UDI
- FDA Product Code
- ODC FDA UDI
- EMDN Code
- Z12029085 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES EUDAMED
- GMDN Term
- Endoscope air/water valve, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Disposable Endoscope Valves Kit by Shanghai SeeGen Photoelectric Technology Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K222499 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697378629VK83 | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015374
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 367a6b01-6c73-430c-a297-b793697c3eab 61 fields · synced Aug 4, 2026
- FDA UDI f046bbd5-f8c7-4068-8b84-b1728a80a652 33 fields · synced May 30, 2026
- FDA 510(k) K222499 1 fields · synced May 18, 2026