69 results · 23ms · Sources: EU EUDAMED, US FDA

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PATH MEDICAL GmbH

Manufacturer
🇩🇪 Germany·6 Basic UDI-DIs·6 Devices

PATH

FDA registration
PATH·6 products·🇩🇪 Germany

PurePrep Path DX Kit (96 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

PurePrep Path DX Kit (480 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

AUDIOMETERS

Device
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·On the market·28 countries

EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES

Device
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·On the market·27 countries

AUDIOMETERS

Device
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·On the market·27 countries

EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES

Device
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·On the market·27 countries

AUDIOMETERS

Device
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·On the market·24 countries

EVOKED POTENTIAL AUDIOMETRY INSTRUMENTS - HARDWARE ACCESSORIES

Device
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·On the market·10 countries

Ear Coupler (PATH)

Basic UDI-DI
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·1 device

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)

FDA Enforcement
Class II ·Ongoing·PATH·December 24, 2025

AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

FDA Enforcement
Class II ·Ongoing·PATH·December 6, 2023

SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

FDA Enforcement
Class II ·Ongoing·PATH·December 6, 2023

SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

FDA Enforcement
Class II ·Ongoing·PATH·December 6, 2023

SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

FDA Enforcement
Class II ·Ongoing·PATH·December 6, 2023

Ear Tips for Ear Probes

Basic UDI-DI
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·1 device

ABR Electrode Cable

Basic UDI-DI
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·1 device

Insert Earphone Tip 10mm

Basic UDI-DI
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·1 device

ALGO 7i ABR Cable long

Basic UDI-DI
EU MDR · Eu Md Class 1 ·PATH MEDICAL GmbH·1 device