Disposable Endoscope Valves Kit
by Shanghai SeeGen Photoelectric Technology Co., Ltd. 6 variants
Ref SG-DVK-FJ-700Model 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
Active
CE MDR
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number06973786290368 | Date25 Oct 2024 | StatusListed |
| European Union | CE/MDR EUDAMED | Number697378629VK83 06973786290368 | Date18 Sep 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Endoscope air/water valve, single-use
- 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
- Primary DI / UDI-DI
- 06973786290368
- Basic UDI-DI
- 697378629VK83
- 510(k) Number
- FDA Product Code
- ODC
- EMDN Code
- Z12029085 Various instruments for endoscopy and mini-invasive surgery - consumables
- GMDN Term
- Endoscope air/water valve, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 876.1500
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000015374
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanghai SeeGen Photoelectric Technology Co., Ltd
See all devices from Shanghai SeeGen Photoelectric Technology Co., Ltd →
Properties
Other properties (18)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No