69 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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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