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Disposable Endoscope Valves Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref SG-DVK-PT-I1090EModel 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-PT-I1090E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973786290405 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697378629VK83 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED b641eee3-179c-4e72-b608-9bdb2a89f6eb 61 fields · synced Jul 10, 2026
- FDA UDI d82a1942-ef2f-4656-94f6-13d2b831aa33 33 fields · synced May 30, 2026