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UPS Ear Probe

by Otodynamics Ltd

Ref PR-UPSModel PROBE

UPS Ear Probe (PR-UPS) is a Class IIa device made by Otodynamics, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 506039617PROBEBU), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506039617PROBEBU Basic UDI-DI 05060396171291UDI-DIDate3 Nov 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Otodynamics Ear Probes
Model / reference
PROBE, PR-UPS
Primary DI / UDI-DI
05060396171291
Basic UDI-DI
506039617PROBEBU
Direct marketing DI
05060396171291
EMDN code
Z12149001 Otoacoustic emissions equipment
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
GB-MF-000018964
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

Other properties (14, all answered No)