Skip to content

Full HD Endoscopic Image Processor

by Scivita Medical Technology Co., Ltd. 3 variants

Ref HDVS-S200CModel HDVS-S200A 、HDVS-S200B 、HDVS-S200C、 HDVS-S200D

Full HD Endoscopic Image Processor (HDVS-S200C) is an endoscopic video image processing unit (EU MDR Class I; FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Scivita Medical Technology Co., Ltd., cleared under FDA 510(k) K240289 on 23 Oct 2024, registered in EUDAMED on 22 May 2024 (Basic UDI-DI 697138125025A8M) and listed in FDA GUDID since 5 Dec 2024 (UDI-DI 06971381252552), 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) K240289

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 Number06971381252552 UDI-DI Date5 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK240289 Date23 Oct 2024IssuedStatusActive
European UnionCE/MDR EUDAMED Number697138125025A8M Basic UDI-DI 06971381252552UDI-DIDate22 May 2024RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K240289 decided 23 Oct 2024 Active
  • EUDAMED Basic UDI-DI 697138125025A8M registered 22 May 2024 Active
  • FDA GUDID UDI-DI 06971381252552 listed 5 Dec 2024 Listed

Timeline

3 dated events

  1. Registered EUDAMED 697138125025A8M
  2. Cleared FDA 510(k) K240289
  3. Listed FDA GUDID 06971381252552

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  • Withdrawn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
HDVS-S200A 、HDVS-S200B 、HDVS-S200C、 HDVS-S200D, HDVS-S200C
Primary DI / UDI-DI
06971381252552
Basic UDI-DI
697138125025A8M
510(k) Number
FDA product code
EOQ
EMDN code
Z12020406 Video processors
GMDN term
Endoscopic video image processing unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Standard device
EU market of registration
Belgium
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.

See all devices from Scivita Medical Technology Co., Ltd. →

Properties

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