Philippines FDA registration MDR-02928B

BRK-1™ TRANSSEPTAL NEEDLE

Philippines·Abbott Vascular (Singapore) Pte. Ltd. - Singapore mfd. By: St. Jude Medical - 14901 DeVeau Place Minnetonka, MN, USA·USA·Issued September 28, 2021 – March 27, 2026

Device information

Product Name: BRK-1™ TRANSSEPTAL NEEDLE
Registration Number: MDR-02928B

Manufacturer details

Manufacturer: Abbott Vascular (Singapore) Pte. Ltd. - Singapore mfd. By: St. Jude Medical - 14901 DeVeau Place Minnetonka, MN, USA
Country of Origin: USA

Importer & distribution

Importer/Distributor: Biodevices, Inc.

Registration dates

Issuance Date: September 28, 2021
Expiry Date: March 27, 2026

About this record

Access comprehensive regulatory information for BRK-1™ TRANSSEPTAL NEEDLE in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-02928B and manufactured by Abbott Vascular (Singapore) Pte. Ltd. - Singapore mfd. By: St. Jude Medical - 14901 DeVeau Place Minnetonka, MN, USA in USA. The device was registered on September 28, 2021.

This page provides complete registration details including manufacturer information, importer/distributor details (Biodevices, Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.