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QScreen Set

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 101199Model PM1610

by PATH medical GmbH

Identity

Trade Name
QScreen EUDAMEDFDA UDI
QScreen Set FDA UDI
Generic Name
Evoked-potential audiometer FDA UDI
Device Name
QScreen EUDAMED
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 101043 Accessory box EP-LT (AB-LT01) P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english FDA UDI
OAE and AEP Hearing Screener FDA UDI
Model / Reference
PM1610 EUDAMEDFDA UDI
101199 EUDAMED
101275-A-EP FDA UDI
Description
Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 101043 Accessory box EP-LT (AB-LT01) P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100337-QScreen FW ABR Quick P/N 100424-QScreen FW Binaural ABR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english FDA UDI
OAE and AEP Hearing Screener FDA UDI

Identifiers

Catalog Number
101199 FDA UDI
Primary DI / UDI-DI
04260223145766 EUDAMEDFDA UDI
04260223146657 FDA UDI
Basic UDI-DI
0426022QScreen-2aDM EUDAMED
510(k) Number
K220139 FDA UDI
FDA Product Code
GWJ FDA UDI
EMDN Code
Z12140302,Z12149001 EUDAMED
GMDN Term
Evoked-potential audiometer FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
882.1900 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDIFDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential audiometer

QScreen Set by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Evoked-potential audiometer.

Cleared under the same submission

K220139 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PATH medical GmbH

Sources (3)

  • FDA UDI 9a95351b-69b1-4e61-ac67-7be8b405bff1 34 fields · synced Jul 26, 2026
  • FDA UDI 189f6b12-e0e1-422f-8b06-1ffa1c57fb69 35 fields · synced May 30, 2026
  • EUDAMED b4e9800e-f337-442c-8b67-9a62816966d0 61 fields · synced Jul 26, 2026