MD Atlas update: Aug 9, 2026

Affimedix, Inc.

US-MF-000053178

Active23 devices

Address: Investment Blvd, 3556 94545 Hayward
Role: Manufacturer
Date of registration: Apr 7, 2026
Country: United States

Affimedix, Inc. is a medical device manufacturer registered in EUDAMED. The company has 23 devices on the EU market across 13 countries. Headquartered in Hayward, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Affimedix, Inc.

: US-MF-000053178
Role: Manufacturer
Country: United States
Organization name: Affimedix, Inc.
EU VAT number: Not applicable
Trade register: 47-1756374
Date of registration: Apr 7, 2026

Contact details for Affimedix, Inc.

Phone: +1 510 398 8111
Email: arun@affimedix.com
Website: https://affimedix.com/
Address: 3556, INVESTMENT BLVD 94545 HAYWARD UNITED STATES

Data export

Export the 23 devices of Affimedix, Inc.

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Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten

Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Officers and regulatory representatives of Affimedix, Inc.

MECCA Susan
(a) conformity of the devices is appropriately checked, in accordance with QMS under which devices are manufactured, before a device is released; (b) TD and EU DOC are drawn up and kept current; (c) PMS obligations are compliant according to Article 10(9); (d) reporting obligations referred to in Articles 82 to 86 e) in case of devices for performance studies intended to be used in the context of other performance studies involving risks for subjects, Section 4.1 of Annex XIV is issued.
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Connected operators

Importers

3 EU importers place 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
25 OH Quantitative Rapid Vitamin D Test	25 OH Quantitative Rapid Vitamin D Test	`GDB7120-25T`	`00850082432226`	1	On the market
BIOSYNEX Rapi-D™ Quantitative Vitamin D Test	BIOSYNEX Rapi-D™ Quantitative Vitamin D Test	`1157Q-25`	`00850082432059`	1	On the market
BodyCheck Ferritin	BodyCheck Ferritin	`A-C52-FERR`	`00850082432073`	1	On the market
BodyCheck Vitamin B12	BodyCheck Vitamin B12	`A-C52-VB12`	`00850082432202`	1	On the market
botissCARE Rapi-D™ Quantitative Vitamin D Test	botissCARE Rapi-D™ Quantitative Vitamin D Test	`1156Q-25`	`00850082432042`	1	On the market
CrinoCheck® Cortisol	CrinoCheck® Cortisol	`A-C42-CORT`	`00850082432134`	1	On the market
CrinoCheck® Testosterone	CrinoCheck® Testosterone	`A-C42-TESTO`	`00850082432103`	1	On the market
CrinoCheck® Vitamin D	CrinoCheck® Vitamin D	`A-C42-VITD25`	`00850082432035`	1	On the market
OnSight™ - Vitamin B12 Quantitative Test	OnSight™ - Vitamin B12 Quantitative Test	`665-25-DB`	`00850082432219`	1	On the market
OnSight™ Cortisol Quantitative Test	OnSight™ Cortisol Quantitative Test	`655-25-DB`	`00850082432141`	1	On the market
OnSight™ Ferritin Quantitative Test	OnSight™ Ferritin Quantitative Test	`670-25-DB`	`00850082432080`	1	On the market
OnSight™ Testosterone Quantitative Test	OnSight™ Testosterone Quantitative Test	`650-25-DB`	`00850082432110`	1	On the market
OnSight™- Vitamin D Quantitative Test	OnSight™- Vitamin D Quantitative Test	`711-25-DB`	`00850082432028`	1	On the market
Rapi-D™ Quantitative Vitamin D Test	Rapi-D™ Quantitative Vitamin D Test	`1155Q-25`	`D-1155Q-25DB`	1	On the market
TestNOW® - Vitamin B12 Quantitative Test	TestNOW® - Vitamin B12 Quantitative Test	`1177Q-25`	`00850082432196`	1	On the market
TestNOW® Cortisol Quantitative Test	TestNOW® Cortisol Quantitative Test	`1175Q-25`	`00850082432127`	1	On the market
TestNOW® Ferritin Quantitative Test	TestNOW® Ferritin Quantitative Test	`1179Q-25`	`00850082432004`	1	On the market
TestNOW® Testosterone Quantitative Test	TestNOW® Testosterone Quantitative Test	`1173Q-25`	`00850082432097`	1	On the market
VHC Vitamin D Test	VHC Vitamin D Test	`1000J-25`	`00850082432066`	1	On the market
Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test	Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test	`1156-VDC`	`00850082432172`	1	On the market
Vitamin D Control – CrinoCheck® Vitamin D	Vitamin D Control – CrinoCheck® Vitamin D	`A-VITD-K`	`00850082432165`	1	On the market
Vitamin D Control – OnSight™ Vitamin D Quantitative Test	Vitamin D Control – OnSight™ Vitamin D Quantitative Test	`711-VDC`	`00850082432189`	1	On the market
Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test	Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test	`1155-VDC`	`00850082432158`	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
25 OH Quantitative Rapid Vitamin D Test	25 OH Quantitative Rapid Vitamin D Test	`GDB7120-25T`	`00850082432226`	1	On the market
BIOSYNEX Rapi-D™ Quantitative Vitamin D Test	BIOSYNEX Rapi-D™ Quantitative Vitamin D Test	`1157Q-25`	`00850082432059`	1	On the market
BodyCheck Ferritin	BodyCheck Ferritin	`A-C52-FERR`	`00850082432073`	1	On the market
BodyCheck Vitamin B12	BodyCheck Vitamin B12	`A-C52-VB12`	`00850082432202`	1	On the market
botissCARE Rapi-D™ Quantitative Vitamin D Test	botissCARE Rapi-D™ Quantitative Vitamin D Test	`1156Q-25`	`00850082432042`	1	On the market
CrinoCheck® Cortisol	CrinoCheck® Cortisol	`A-C42-CORT`	`00850082432134`	1	On the market
CrinoCheck® Testosterone	CrinoCheck® Testosterone	`A-C42-TESTO`	`00850082432103`	1	On the market
CrinoCheck® Vitamin D	CrinoCheck® Vitamin D	`A-C42-VITD25`	`00850082432035`	1	On the market
OnSight™ - Vitamin B12 Quantitative Test	OnSight™ - Vitamin B12 Quantitative Test	`665-25-DB`	`00850082432219`	1	On the market
OnSight™ Cortisol Quantitative Test	OnSight™ Cortisol Quantitative Test	`655-25-DB`	`00850082432141`	1	On the market
OnSight™ Ferritin Quantitative Test	OnSight™ Ferritin Quantitative Test	`670-25-DB`	`00850082432080`	1	On the market
OnSight™ Testosterone Quantitative Test	OnSight™ Testosterone Quantitative Test	`650-25-DB`	`00850082432110`	1	On the market
OnSight™- Vitamin D Quantitative Test	OnSight™- Vitamin D Quantitative Test	`711-25-DB`	`00850082432028`	1	On the market
Rapi-D™ Quantitative Vitamin D Test	Rapi-D™ Quantitative Vitamin D Test	`1155Q-25`	`D-1155Q-25DB`	1	On the market
TestNOW® - Vitamin B12 Quantitative Test	TestNOW® - Vitamin B12 Quantitative Test	`1177Q-25`	`00850082432196`	1	On the market
TestNOW® Cortisol Quantitative Test	TestNOW® Cortisol Quantitative Test	`1175Q-25`	`00850082432127`	1	On the market
TestNOW® Ferritin Quantitative Test	TestNOW® Ferritin Quantitative Test	`1179Q-25`	`00850082432004`	1	On the market
TestNOW® Testosterone Quantitative Test	TestNOW® Testosterone Quantitative Test	`1173Q-25`	`00850082432097`	1	On the market
VHC Vitamin D Test	VHC Vitamin D Test	`1000J-25`	`00850082432066`	1	On the market
Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test	Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test	`1156-VDC`	`00850082432172`	1	On the market
Vitamin D Control – CrinoCheck® Vitamin D	Vitamin D Control – CrinoCheck® Vitamin D	`A-VITD-K`	`00850082432165`	1	On the market
Vitamin D Control – OnSight™ Vitamin D Quantitative Test	Vitamin D Control – OnSight™ Vitamin D Quantitative Test	`711-VDC`	`00850082432189`	1	On the market
Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test	Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test	`1155-VDC`	`00850082432158`	1	On the market

Affimedix, Inc.

About Affimedix, Inc.

Contact details for Affimedix, Inc.

Export the 23 devices of Affimedix, Inc.

Competent authority

Officers and regulatory representatives of Affimedix, Inc.

Connected operators

Importers

Related searches

About Affimedix, Inc.

Contact details for Affimedix, Inc.

Export the 23 devices of Affimedix, Inc.

Competent authority

Officers and regulatory representatives of Affimedix, Inc.

Statistics for Affimedix, Inc.

Certificate health for Affimedix, Inc.

Devices by risk class

Market presence of Affimedix, Inc.

Device catalog for Affimedix, Inc.

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

Connected operators

Importers

Related searches

Market presence of Affimedix, Inc.

Devices by risk class

Certificate health for Affimedix, Inc.

Statistics for Affimedix, Inc.

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

Device catalog for Affimedix, Inc.