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BioSensics, LLC — Manufacturer in United States

MD Atlas update: Jun 28, 2026

BL

BioSensics, LLC

US-MF-000040296

Active

Address: Chapel Street, 57 02458 Newton
Role: Manufacturer
Date of registration: Feb 16, 2024
Country: United States

About BioSensics, LLC

: US-MF-000040296
Role: Manufacturer
Country: United States
Organization name: BioSensics, LLC
EU VAT number: Not applicable
Date of registration: Feb 16, 2024

Contact details for BioSensics, LLC

Phone: 8034035749
Email: kevin.borth@biosensics.com
Website: www.biosensics.com
Address: 57, CHAPEL STREET SUITE 200 NEWTON, MA 02458 UNITED STATES 02458 NEWTON UNITED STATES

Competent authority

Name: Malta Medicines Authority

Phone: +356 23439000
Email: devices.medicinesauthority@gov.mt

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Officers and regulatory representatives of BioSensics, LLC

BORTH Kevin
Responsibilities indicated in Article 15 of the EU IVDR/MDR, including ensuring: The conformity of the devices is correct in accordance with the QMS prior to release. The technical documentation and DoC are drawn up and kept up to date. The PMS obligations are complied with and the reporting obligations are fulfilled.
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Medical device manufacturers in EUDAMED

SRN

An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.

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SRN

An SRN is the unique EUDAMED identifier assigned to a manufacturer, authorised representative or importer when it registers as an actor.

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Certificate health for BioSensics, LLC

No certificates registered for this manufacturer.

Statistics for BioSensics, LLC

0Total Devices

0Basic UDI-DIs

0Documents

0Certificates

0Valid

0Expiring < 6 months

0Countries

BioSensics, LLC is a medical device manufacturer registered in EUDAMED. Headquartered in Newton, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

Device families (Basic UDI-DI) of BioSensics, LLC

No device families registered for this manufacturer.

Device catalog for BioSensics, LLC

No devices registered for this manufacturer.