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Disposable Endoscope Valves Set B
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref -Model WS-VP-B
Identity
- Trade Name
- Disposable Endoscope Valves Set B EUDAMED
- Device Name
- Disposable Endoscope Valves Set B EUDAMED
- Model / Reference
- WS-VP-B EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944233425305 EUDAMED
- Basic UDI-DI
- B-06944233425305 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastro-urological guidewire, single-use
Disposable Endoscope Valves Set B by Wilson Instruments (SHA) Co., Ltd. — Class I — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200769 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06944233425305 | Class I | Active |
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Manufacturer
- Manufacturer
- Wilson Instruments (SHA) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 738ec7c5-fbb1-4fc0-b4ba-1d336f561054 61 fields · synced Jul 9, 2026
- FDA 510(k) K200769 1 fields · synced May 18, 2026