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Otoport Mini Printer V2 package OPRO-PP

by Otodynamics

Ref OPRO-PPModel PRINTER

Otoport Mini Printer V2 package OPRO-PP is a device classified as Class I in the EU and Class II in the US made by Otodynamics, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 506039617PRINTERS7), cleared under FDA 510(k) K240430 on 15 Mar 2024 and listed in FDA GUDID since 17 Jul 2024 (UDI-DI 05060396173370), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240430

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506039617PRINTERS7 Basic UDI-DI 05060396173370UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060396173370 UDI-DI Date17 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK240430 Date15 Mar 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506039617PRINTERS7 registered 4 Nov 2026 Active
  • FDA 510(k) K240430 decided 15 Mar 2024 Active
  • FDA GUDID UDI-DI 05060396173370 listed 17 Jul 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240430
  2. Listed FDA GUDID 05060396173370
  3. Registered EUDAMED 506039617PRINTERS7

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  • Withdrawn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

Trade name
Otoport Mini Printer V2 package
Generic name
Otoacoustic emission system, battery-powered
Device name
Otodynamics Printers
Model / reference
OPRO-PP, PRINTER
Primary DI / UDI-DI
05060396173370
Basic UDI-DI
506039617PRINTERS7
Direct marketing DI
05060396173370
510(k) Number
FDA product code
EWO, GWJ
EMDN code
Z12149001 Otoacoustic emissions equipment
GMDN term
Otoacoustic emission system, battery-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.1050, 882.1900
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Evoked-potential audiometerOtoacoustic emission system, battery-powered

Cleared under the same submission (K240430)

and 8 more cleared under K240430

Similar devices in this category

Other devices filed under OTOACOUSTIC EMISSIONS EQUIPMENT.

Other devices from Otodynamics

See all devices from Otodynamics →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)