Skip to content

WiScope

by Ningbo Wise OptoMech Technology Corporation 8 variants

Part of a family of 8 devices: see the family page

Ref OTU-100SLModel OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-C380RL, OTU-C380RR, OTU-C380SL, OTU-C380SR,

WiScope (OTU-100SL) is a flexible video ureteroscope (EU MDR Class IIa; FDA Class II; FDA product code FGB, Ureteroscope And Accessories, Flexible/Rigid) made by Ningbo Wise Optomech Technology Corporation, registered in EUDAMED on 28 Apr 2026 (Basic UDI-DI 697208414003H3) and listed in FDA GUDID since 10 Jan 2019 (UDI-DI 06972084140030), 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 Number697208414003H3 Basic UDI-DI 06972084140030UDI-DIDate28 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06972084140030 UDI-DI Date10 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697208414003H3 registered 28 Apr 2026 Active
  • FDA GUDID UDI-DI 06972084140030 listed 10 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06972084140030
  2. Registered EUDAMED 697208414003H3

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  • Withdrawn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
Flexible video ureteroscope, single-use
Device name
Single-Use Digital Flexible Endoscope
Model / reference
OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-C380RL, OTU-C380RR, OTU-C380SL, OTU-C380SR
Primary DI / UDI-DI
06972084140030
Basic UDI-DI
697208414003H3
FDA product code
FGB
EMDN code
Z12020713 Ureterorenoscopes
GMDN term
Flexible video ureteroscope, single-use
Device class
Class IIa 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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

Related devices

Category: Flexible video ureteroscope, single-use

Similar devices in this category

Other devices filed under URETERORENOSCOPES.

Other devices from Ningbo Wise Optomech Technology Corporation

  • WiScope

    Class IIa

  • WiScope

    Class IIa

  • WiScope

    Class IIa

  • WiScope

    Class I

See all devices from Ningbo Wise Optomech Technology Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)