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3D Visualization System

by Scivita Medical Technology Co., Ltd. 5 variants

Ref 3DVS-S100BModel 3DVS-S100A,3DVS-S100B,3DVS-S100C,3DVS-S100D,3DVS-S100E

3D Visualization System (3DVS-S100B) is an endoscopic video image processing unit (EU MDR Class I; FDA Class II; FDA product code GCJ, Laparoscope, General & Plastic Surgery) made by Scivita Medical Technology Co., Ltd., registered in EUDAMED on 3 Nov 2021 (Basic UDI-DI 697138125001A7X), cleared under FDA 510(k) K183675 on 25 Sep 2019 and listed in FDA GUDID since 17 May 2023 (UDI-DI 06971381250022), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183675

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971381250022 UDI-DI Date17 May 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697138125001A7X Basic UDI-DI 06971381250022UDI-DIDate3 Nov 2021RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK183675 Date25 Sep 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697138125001A7X registered 3 Nov 2021 Active
  • FDA 510(k) K183675 decided 25 Sep 2019 Active
  • FDA GUDID UDI-DI 06971381250022 listed 17 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183675
  2. Registered EUDAMED 697138125001A7X
  3. Listed FDA GUDID 06971381250022

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Endoscopic video image processing unit
Model / reference
3DVS-S100A, 3DVS-S100B, 3DVS-S100C, 3DVS-S100D, 3DVS-S100E
Primary DI / UDI-DI
06971381250022
Basic UDI-DI
697138125001A7X
Direct marketing DI
06971381250022
510(k) Number
FDA product code
GCJ
EMDN code
Z12020406 Video processors
GMDN term
Endoscopic video image processing unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000010305
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

Other devices from Scivita Medical Technology Co., Ltd.

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Properties

  • Reusable
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)