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Aptra

by Otu Medical Inc.

Ref BDSD02Model OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S,

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850023925002RF Basic UDI-DI 00850023925961UDI-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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Single-Use Digital Flexible Ureteroscope
Model / Reference
OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S, BDSD02
Primary DI / UDI-DI
00850023925961
Basic UDI-DI
0850023925002RF
EMDN Code
Z12020713 Ureterorenoscopes
Device Class
Class IIa
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
US-MF-000020690
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Otu Medical Inc.

See all devices from Otu Medical Inc. →

Properties

  • Sterile

Other properties (12)

  • 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