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WiScope® OTU-CK320R

by Otu Medical Inc.

Ref OTU-CK320RModel OTU-C300S, OTU-C300R, OTU-C310S, OTU-C310R, OTU-C311S, OTU-C311R, OTU-C380SL, OTU-C380RL, OTU-C380SR, OTU-C380RR, OTU-C320S, OTU-C320R, OTU-C330S, OTU-C330R

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850023925916 UDI-DI Date28 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0850023925005RM Basic UDI-DI 00850023925916UDI-DIDate20 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
WiScope EUDAMED
WiScope® GUDID
Generic Name
Flexible video cystoscope, single-use
Model / Reference
OTU-CK320R, OTU-C300S, OTU-C300R, OTU-C310S, OTU-C310R, OTU-C311S, OTU-C311R, OTU-C380SL, OTU-C380RL, OTU-C380SR, OTU-C380RR, OTU-C320S, OTU-C320R, OTU-C330S, OTU-C330R
Primary DI / UDI-DI
00850023925916
Basic UDI-DI
0850023925005RM
510(k) Number
FDA Product Code
FAJ
EMDN Code
Z12020701 Cystoscopes
GMDN Term
Flexible video cystoscope, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
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

Related devices

Cleared under the same submission (K231702)

Other devices from Otu Medical Inc.

See all devices from Otu Medical Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No