17 results · 20ms · Sources: EU EUDAMED, US FDA

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Phönix-PACS GmbH

Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·4 Devices

Omni-Pac GmbH Verpackungsmittel

Manufacturer
🇩🇪 Germany

²³Na / ¹H Breast Array

Device
EU MDR · Eu Md Class 2a ·RAPID Biomedical GmbH·On the market·2 countries

VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDD · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Device
EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·On the market

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

MERLIN Diagnostic Workcenter

Basic UDI-DI
EU MDD · Eu Md Class 1 ·Phönix-PACS GmbH·1 device

MERLIN Diagnostic Workcenter

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Phönix-PACS GmbH·3 devices

JAH GmbH

Importer
🇩🇪 Germany

Llins Service & Consulting GmbH

Authorized representative
🇩🇪 Germany·39 Manufacturers·556 Devices

Maxcert Eurep

Authorized representative
🇩🇪 Germany·65 Manufacturers·8 Devices