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QScreen Set 101275-A-EP

by PATH medical GmbH

Ref 101199Model PM1610

QScreen Set 101275-A-EP is a device classified as Class IIa in the EU and Class II in the US made by PATH medical GmbH, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 0426022QScreen-2aDM), cleared under FDA 510(k) K220139 on 3 Aug 2022 and listed in FDA GUDID since 19 May 2023 (UDI-DI 04260223145766), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220139

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0426022QScreen-2aDM Basic UDI-DI 04260223145766UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260223145766 UDI-DI Date19 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220139 Date3 Aug 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0426022QScreen-2aDM registered 28 May 2026 Active
  • FDA 510(k) K220139 decided 3 Aug 2022 Active
  • FDA GUDID UDI-DI 04260223145766 listed 19 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220139
  2. Listed FDA GUDID 04260223145766
  3. Registered EUDAMED 0426022QScreen-2aDM

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  • Withdrawn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
QScreen EUDAMEDGUDID
QScreen Set GUDID
Generic name
Evoked-potential audiometer
Model / Ref / Catalog
PM1610, 101199, 101275-A-EP
Description
OAE and AEP Hearing Screener
Primary DI / UDI-DI
04260223145766, 04260223146657
Basic UDI-DI
0426022QScreen-2aDM
510(k) Number
FDA product code
GWJ
EMDN code
Z12140302, Z12149001
GMDN term
Evoked-potential audiometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1900
System or procedure pack
System which is a device in itself
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 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.

Related devices

Category: Evoked-potential audiometer

Cleared under the same submission (K220139)

and 8 more cleared under K220139

Similar devices in this category

Other devices filed under EVOKED POTENTIAL AUDIOMETRY EQUIPMENTS.

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Measuring function
  • Prescription use
  • Convenience kit YesGUDIDNoGUDID
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)