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WiScope

by Otu Medical Inc. 24 variants

Part of a family of 15 devices: see the family page

Ref OTU-130RModel OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S,

WiScope (OTU-130R) is a device classified as Class IIa in the EU and Class II in the US made by Otu Medical Inc., registered in EUDAMED on 20 Oct 2025 (Basic UDI-DI 0850023925002RF), cleared under FDA 510(k) K181977 on 14 Aug 2018 and listed in FDA GUDID since 28 Jul 2026 (UDI-DI 00850023925640), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181977

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850023925640 UDI-DI Date28 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0850023925002RF Basic UDI-DI 00850023925640UDI-DIDate20 Oct 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181977 Date14 Aug 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0850023925002RF registered 20 Oct 2025 Active
  • FDA 510(k) K181977 decided 14 Aug 2018 Active
  • FDA GUDID UDI-DI 00850023925640 listed 28 Jul 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181977
  2. Registered EUDAMED 0850023925002RF
  3. Listed FDA GUDID 00850023925640

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  • Withdrawn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
Flexible video ureteroscope, single-use
Model / reference
OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S, OTU-130R
Primary DI / UDI-DI
00850023925640
Basic UDI-DI
0850023925002RF
510(k) Number
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
US-MF-000020690
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under URETERORENOSCOPES.

Other devices from Otu Medical Inc.

  • Aptra

    Class IIa

  • WiScope® OTU-T Pro

    Class II

  • WiScope® OTU-140S

    Class II

  • WiScope® OTU-110R

    Class II

See all devices from Otu Medical Inc. →

Properties

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