Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017845262

FEI Number

3017845262

Entity Name

Agendia NV

City/State/Country

Amsterdam Noord-Holland, NL

Establishment Address

Radarweg 60, Amsterdam Noord-Holland 1043 NT, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AGENDIA Inc. (Owner Number: 9101719)

Owner / Operator Contact Address

Agendia Inc., 22 Morgan, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141142

PMA Number

N/A

All Registered Proprietary Names

MammaPrint® FFPE MammaPrint® FFPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NYI	Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer	Immunology	Class 2	866.6040	2022-11-02
NYI	Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer	Immunology	Class 2	866.6040	2018-11-27

Official Correspondent

Melissa Chavis

US Agent Details

Melissa Chavis Business: Agendia Inc. Email: melissa.chavis@agendia.com Phone: (858) 7223685

Related Public Records

Same Entity

AGENDIA Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007297853	Agendia Inc	Irvine, CA, US

Similar Registrations

Registration Number	Establishment Name	Location
3007297853	Agendia Inc	Irvine, CA, US
3039487170	HELIO DIAGNOSTICS SAS	Marseille Bouches-du-Rhone, FR
2032839	EPITOPE DIAGNOSTICS, INC.	SAN DIEGO, CA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017845262. Last updated year: 2026. Please use registration number 3017845262 when referencing this establishment in official correspondence.