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WiScope

by Otu Medical Inc. 24 variants

Ref OTU-BR02Model OTU-BR01, OTU-BR02, OTU-BR03

WiScope (OTU-BR02) is a flexible video bronchoscope (EU MDR Class IIa; FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Otu Medical Inc., registered in EUDAMED on 22 Oct 2025 (Basic UDI-DI 0850023925007RR), cleared under FDA 510(k) K220399 on 16 Jun 2022 and listed in FDA GUDID since 30 Apr 2023 (UDI-DI 00850023925213), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220399

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850023925007RR Basic UDI-DI 00850023925213UDI-DIDate22 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00850023925213 UDI-DI Date30 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220399 Date16 Jun 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0850023925007RR registered 22 Oct 2025 Active
  • FDA 510(k) K220399 decided 16 Jun 2022 Active
  • FDA GUDID UDI-DI 00850023925213 listed 30 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220399
  2. Listed FDA GUDID 00850023925213
  3. Registered EUDAMED 0850023925007RR

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  • Withdrawn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 bronchoscope, single-use
Model / reference
OTU-BR01, OTU-BR02, OTU-BR03
Primary DI / UDI-DI
00850023925213
Basic UDI-DI
0850023925007RR
510(k) Number
FDA product code
EOQ
EMDN code
Z12020801 Bronchoscopes
GMDN term
Flexible video bronchoscope, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4680
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 BRONCHOSCOPES.

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)