MD Atlas update: Jun 16, 2026

Gynesonics, Inc.

US-PR-000012728

System / procedure pack producerActive

Address: Chesapeake Dr., 600 94063 Redwood City
Role: System / procedure pack producer
Date of registration: Sep 6, 2021
Country: United States

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Gynesonics, Inc. is a system and procedure pack producer registered in EUDAMED. Headquartered in Redwood City, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

Role
Country
Date of registration
Address

MD Atlas update: Jun 16, 2026

Gynesonics, Inc.

US-PR-000012728

System / procedure pack producerActive

Address: Chesapeake Dr., 600 94063 Redwood City
Role: System / procedure pack producer
Date of registration: Sep 6, 2021
Country: United States

Is this your company? Claim it to add your logo, story and links — free.Claim this page

Gynesonics, Inc. is a system and procedure pack producer registered in EUDAMED. Headquartered in Redwood City, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Gynesonics, Inc.

SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: US-PR-000012728
Role: System / procedure pack producer
Country: United States
Organization name: Gynesonics, Inc.
EU VAT number: Not applicable
Date of registration: Sep 6, 2021

Contact details for Gynesonics, Inc.

Phone: +1 650-216-3860
Email: regulatory@gynesonics.com
Website: www.gynesonics.com
Address: 600, CHESAPEAKE DR. 94063 REDWOOD CITY UNITED STATES

Competent authority

Name: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
SRN An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor. View in glossary →: BE-CA-007
Phone: +32 2 528 40 00
Email: notifications.meddev@fagg-afmps.be

Role and obligations in EUDAMED

A producer of systems or procedure packs combines CE-marked devices to place a system or procedure pack on the market under the conditions of Article 22 of the MDR (2017/745).