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WiScope

by Ningbo Wise OptoMech Technology Corporation 2 variants

Ref OTU-TModel OTU-A, OTU-T,

WiScope (OTU-T) is an endoscopic video image processing unit (EU MDR Class I; FDA Class II; FDA product code FAJ, Cystoscope And Accessories, Flexible/Rigid) made by Ningbo Wise Optomech Technology Corporation, registered in EUDAMED on 29 Apr 2026 (Basic UDI-DI 697208414005H7) and listed in FDA GUDID since 12 Jan 2024 (UDI-DI 06972084140412), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697208414005H7 Basic UDI-DI 06972084140412UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06972084140412 UDI-DI Date12 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697208414005H7 registered 29 Apr 2026 Active
  • FDA GUDID UDI-DI 06972084140412 listed 12 Jan 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06972084140412
  2. Registered EUDAMED 697208414005H7

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  • Withdrawn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

Generic name
Endoscopic video image processing unit
Device name
Image System/Medical Tablet
Model / Ref / Catalog
OTU-A, OTU-T, 4202T0201W
Primary DI / UDI-DI
06972084140412
Basic UDI-DI
697208414005H7
FDA product code
FAJ
EMDN code
Z12020406 Video processors
GMDN term
Endoscopic video image processing unit
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Northern Ireland
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-000036849
Authorised representative
Prolinx GmbH DE-AR-000005129

Similar devices in this category

Other devices filed under VIDEO PROCESSORS.

Other devices from Ningbo Wise Optomech Technology Corporation

  • WiScope

    Class IIa

  • WiScope

    Class IIa

  • WiScope

    Class IIa

  • WiScope

    Class IIa

See all devices from Ningbo Wise Optomech Technology Corporation →

Properties

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