EUDAMED update: May 8, 2026

Affymetrix, Inc.

US-MF-000028847

Active12 devices

Address: 3450 Central Expressway, 95051 Santa Clara
Role: Manufacturer
Date of registration: Sep 23, 2022
Country: United States

Affymetrix, Inc. is a medical device manufacturer registered in EUDAMED. The company has 12 devices on the EU market across 2 countries. Headquartered in Santa Clara, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Affymetrix, Inc.

: US-MF-000028847
Role: Manufacturer
Country: United States
Organization name: Affymetrix, Inc.
EU VAT number: Not applicable
Date of registration: Sep 23, 2022

Contact details for Affymetrix, Inc.

Email: jody.schulz@thermofisher.com
Address: 3450 CENTRAL EXPRESSWAY 95051 SANTA CLARA UNITED STATES

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Competent authority

Name: Ministerie van Volksgezondheid, Welzijn en Sport

Phone: +31 70 340 79 11
Email: medische_hulpmiddelen@minvws.nl

Officers and regulatory representatives of Affymetrix, Inc.

SCHULZ Jody
Responsible for regulatory.
Hidden
BOUGHEN Kerrie
Responsible for Quality
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
Chromosome Analysis Suite Dx Software (ChAS Dx)	Chromosome Analysis Suite Dx Software (ChAS Dx)	`610525`	`00856826006210`	1	On the market
CytoScan Dx Array, 6 pk	CytoScan Dx Array, 6 pk	`902150 (902420)`	`00856826006098`	1	On the market
CytoScan Dx Post-PCR -20°C MOD F L H	CytoScan Dx Post-PCR -20°C MOD F L H	`902109 (902420)`	`00856826006128`	1	On the market
CytoScan Dx Post-PCR 15°-30°C MOD E PW	CytoScan Dx Post-PCR 15°-30°C MOD E PW	`902111 (902420)`	`00856826006166`	1	On the market
CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB	CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB	`902110 (902420)`	`00856826006135`	1	On the market
CytoScan Dx Pre-PCR -20°C MOD R L A	CytoScan Dx Pre-PCR -20°C MOD R L A	`902107 (902420)`	`00856826006142`	1	On the market
CytoScan Dx Pre-PCR 2°-8°C MOD T E W	CytoScan Dx Pre-PCR 2°-8°C MOD T E W	`902108 (902420)`	`00856826006159`	1	On the market
CytoScan Dx Wash Solution A	CytoScan Dx Wash Solution A	`902090 (902420)`	`00856826006104`	1	On the market
CytoScan Dx Wash Solution B	CytoScan Dx Wash Solution B	`902091 (902420)`	`00856826006111`	1	On the market
GCDC Dx Installer v1.0	GCDC Dx Installer v1.0	`611403 (00-0334)`	`00856826006203`	1	On the market
GeneChip™ Fluidics Station FS450Dx v.2	GeneChip™ Fluidics Station FS450Dx v.2	`00-0335 (00-0334)`	`00856826006029`	1	On the market
GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2	GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2	`00-0336 (00-0334)`	`00856826006036`	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
Chromosome Analysis Suite Dx Software (ChAS Dx)	Chromosome Analysis Suite Dx Software (ChAS Dx)	`610525`	`00856826006210`	1	On the market
CytoScan Dx Array, 6 pk	CytoScan Dx Array, 6 pk	`902150 (902420)`	`00856826006098`	1	On the market
CytoScan Dx Post-PCR -20°C MOD F L H	CytoScan Dx Post-PCR -20°C MOD F L H	`902109 (902420)`	`00856826006128`	1	On the market
CytoScan Dx Post-PCR 15°-30°C MOD E PW	CytoScan Dx Post-PCR 15°-30°C MOD E PW	`902111 (902420)`	`00856826006166`	1	On the market
CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB	CytoScan Dx Post-PCR 2°-8°C MOD S AH W PB	`902110 (902420)`	`00856826006135`	1	On the market
CytoScan Dx Pre-PCR -20°C MOD R L A	CytoScan Dx Pre-PCR -20°C MOD R L A	`902107 (902420)`	`00856826006142`	1	On the market
CytoScan Dx Pre-PCR 2°-8°C MOD T E W	CytoScan Dx Pre-PCR 2°-8°C MOD T E W	`902108 (902420)`	`00856826006159`	1	On the market
CytoScan Dx Wash Solution A	CytoScan Dx Wash Solution A	`902090 (902420)`	`00856826006104`	1	On the market
CytoScan Dx Wash Solution B	CytoScan Dx Wash Solution B	`902091 (902420)`	`00856826006111`	1	On the market
GCDC Dx Installer v1.0	GCDC Dx Installer v1.0	`611403 (00-0334)`	`00856826006203`	1	On the market
GeneChip™ Fluidics Station FS450Dx v.2	GeneChip™ Fluidics Station FS450Dx v.2	`00-0335 (00-0334)`	`00856826006029`	1	On the market
GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2	GeneChip™ Scanner 3000Dx v.2 with AutoLoaderDx v2	`00-0336 (00-0334)`	`00856826006036`	1	On the market

Affymetrix, Inc.

About Affymetrix, Inc.

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About Affymetrix, Inc.

Contact details for Affymetrix, Inc.

Export the 12 devices of Affymetrix, Inc.

Competent authority

Officers and regulatory representatives of Affymetrix, Inc.

Statistics for Affymetrix, Inc.

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Market presence of Affymetrix, Inc.

Device catalog for Affymetrix, Inc.

Device families (Basic UDI-DI) of Affymetrix, Inc.

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Importers

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Market presence of Affymetrix, Inc.

Devices by risk class

Certificate health for Affymetrix, Inc.

Statistics for Affymetrix, Inc.

Device families (Basic UDI-DI) of Affymetrix, Inc.

Device catalog for Affymetrix, Inc.