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ViewHub S13-T

by MacroLux Medical Technology Co., Ltd. 2 variants

Part of a family of 14 devices: see the family page

Ref S13-T, S13Model S13, S13-T, S13-N, S13-S

ViewHub S13-T is a device classified as Class I in the EU and Class II in the US made by MacroLux Medical Technology Co., Ltd., registered in EUDAMED on 29 Oct 2025 (Basic UDI-DI 697533962002ML) and listed in FDA GUDID since 23 Aug 2025 (UDI-DI 06975339626679), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697533962002ML Basic UDI-DI Date29 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06975339626679 UDI-DI Date23 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697533962002ML registered 29 Oct 2025 Active
  • FDA GUDID UDI-DI 06975339626679 listed 23 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06975339626679
  2. Registered EUDAMED 697533962002ML

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
ViewHub
Generic name
Endoscopic video image processing unit
Model / reference
S13-T, S13, S13-N, S13-S
Primary DI / UDI-DI
06975339626679, 06975339626686, 06975339626471, 06975339626433, 06975339626440
Basic UDI-DI
697533962002ML
Direct marketing DI
06975339626471
06975339626686
06975339626433
06975339626440
06975339626679
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
France
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.

Related devices

Category: Endoscopic video image processing unit

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

Other devices from MacroLux Medical Technology Co., Ltd.

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

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)