EUDAMED update: Feb 13, 2026

Inova Diagnostics. Inc.

US-MF-000017851

Active192 devices

Address: Old Grove Road, 9900 92131 San Diego
Role: Manufacturer
Date of registration: Dec 9, 2021
Country: United States

Inova Diagnostics. Inc. is a medical device manufacturer registered in EUDAMED. The company has 192 devices on the EU market across 28 countries. Headquartered in San Diego, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Inova

: US-MF-000017851
Role: Manufacturer
Country: United States
Organization name: Inova Diagnostics. Inc.
EU VAT number: Not applicable
Date of registration: Dec 9, 2021

Contact details for Inova

Phone: +1 858 586 9900 Ex. 77346
Email: rwilson@werfen.com
Website: werfen.com
Address: 9900, OLD GROVE ROAD 92131 SAN DIEGO UNITED STATES

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Competent authority

Name: DE/CA70 - Landesamt für Umwelt- und Arbeitsschutz

Phone: +49 6818500-0
Email: koordination_marktueberwachung@lua.saarland.de

Officers and regulatory representatives of Inova

BRIDGES Constance
Inova Diagnostics, Inc. as VP of Quality and Regulatory Affairs
Hidden

Connected operators

Importers

1 EU importer places this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Aptiva	Aptiva	`724121`	`08430793040570`	1	On the market
QUANTA Flash	QUANTA Flash	`701148`	`08426950595878`	1	On the market
Aptiva	Aptiva	`723102`	`08430793040198`	1	On the market
Aptiva	Aptiva	`723100`	`08430793040051`	1	On the market
Aptiva	Aptiva	`723101`	`08430793040181`	1	On the market
Aptiva	Aptiva	`724102`	`08430793040525`	1	On the market
Aptiva	Aptiva	`724100`	`08430793040471`	1	On the market
Aptiva	Aptiva	`724120`	`08430793040532`	1	On the market
Aptiva	Aptiva	`724101`	`08430793040518`	1	On the market
Aptiva	Aptiva	`724122`	`08430793040587`	1	On the market
Aptiva Instrument System Cuvettes	Aptiva Instrument System Cuvettes	`AC1005`	`00195126000741`	1	On the market
Aptiva System Cleaning Solution Kit	Aptiva System Cleaning Solution Kit	`AC1003`	`00195126000871`	1	On the market
Aptiva® APS IgA Calibrators	Aptiva® APS IgA Calibrators	`725121`	`08430793040839`	1	On the market
Aptiva® APS IgA Controls	Aptiva® APS IgA Controls	`725122`	`08430793040846`	1	On the market
Aptiva® APS IgA Reagent	Aptiva® APS IgA Reagent	`725120`	`08430793040785`	1	On the market
Aptiva® APS IgG Calibrators	Aptiva® APS IgG Calibrators	`725101`	`08430793040761`	1	On the market
Aptiva® APS IgG Controls	Aptiva® APS IgG Controls	`725102`	`08430793040778`	1	On the market
Aptiva® APS IgG Reagent	Aptiva® APS IgG Reagent	`725100`	`08430793040716`	1	On the market
Aptiva® APS IgM Calibrators	Aptiva® APS IgM Calibrators	`725141`	`08430793040907`	1	On the market
Aptiva® APS IgM Controls	Aptiva® APS IgM Controls	`725142`	`08430793040914`	1	On the market
Aptiva® APS IgM Reagent	Aptiva® APS IgM Reagent	`725140`	`08430793040853`	1	On the market
Aptiva® CTD Essential Calibrators	Aptiva® CTD Essential Calibrators	`723101`	`08430793040181`	1	On the market
Aptiva® CTD Essential Controls	Aptiva® CTD Essential Controls	`723102`	`08430793040198`	1	On the market
Aptiva® CTD Essential Reagent	Aptiva® CTD Essential Reagent	`723100`	`08430793040051`	1	On the market
Aptiva® Multi-Analyte Instrument	Aptiva® Multi-Analyte Instrument	`AP5000`	`08426951307227`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Aptiva	Aptiva	`724121`	`08430793040570`	1	On the market
QUANTA Flash	QUANTA Flash	`701148`	`08426950595878`	1	On the market
Aptiva	Aptiva	`723102`	`08430793040198`	1	On the market
Aptiva	Aptiva	`723100`	`08430793040051`	1	On the market
Aptiva	Aptiva	`723101`	`08430793040181`	1	On the market
Aptiva	Aptiva	`724102`	`08430793040525`	1	On the market
Aptiva	Aptiva	`724100`	`08430793040471`	1	On the market
Aptiva	Aptiva	`724120`	`08430793040532`	1	On the market
Aptiva	Aptiva	`724101`	`08430793040518`	1	On the market
Aptiva	Aptiva	`724122`	`08430793040587`	1	On the market
Aptiva Instrument System Cuvettes	Aptiva Instrument System Cuvettes	`AC1005`	`00195126000741`	1	On the market
Aptiva System Cleaning Solution Kit	Aptiva System Cleaning Solution Kit	`AC1003`	`00195126000871`	1	On the market
Aptiva® APS IgA Calibrators	Aptiva® APS IgA Calibrators	`725121`	`08430793040839`	1	On the market
Aptiva® APS IgA Controls	Aptiva® APS IgA Controls	`725122`	`08430793040846`	1	On the market
Aptiva® APS IgA Reagent	Aptiva® APS IgA Reagent	`725120`	`08430793040785`	1	On the market
Aptiva® APS IgG Calibrators	Aptiva® APS IgG Calibrators	`725101`	`08430793040761`	1	On the market
Aptiva® APS IgG Controls	Aptiva® APS IgG Controls	`725102`	`08430793040778`	1	On the market
Aptiva® APS IgG Reagent	Aptiva® APS IgG Reagent	`725100`	`08430793040716`	1	On the market
Aptiva® APS IgM Calibrators	Aptiva® APS IgM Calibrators	`725141`	`08430793040907`	1	On the market
Aptiva® APS IgM Controls	Aptiva® APS IgM Controls	`725142`	`08430793040914`	1	On the market
Aptiva® APS IgM Reagent	Aptiva® APS IgM Reagent	`725140`	`08430793040853`	1	On the market
Aptiva® CTD Essential Calibrators	Aptiva® CTD Essential Calibrators	`723101`	`08430793040181`	1	On the market
Aptiva® CTD Essential Controls	Aptiva® CTD Essential Controls	`723102`	`08430793040198`	1	On the market
Aptiva® CTD Essential Reagent	Aptiva® CTD Essential Reagent	`723100`	`08430793040051`	1	On the market
Aptiva® Multi-Analyte Instrument	Aptiva® Multi-Analyte Instrument	`AP5000`	`08426951307227`	1	On the market

Inova Diagnostics. Inc.

About Inova

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About Inova

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Export the 192 devices of Inova

Competent authority

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Statistics for Inova

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Certificate health for Inova

Statistics for Inova

Market presence of Inova

Devices by risk class

Device catalog for Inova

Device families (Basic UDI-DI) of Inova