Philippines FDA registration MDR-09002B

UNIFY ASSURA™ CARDIAC RESYNCHRONIZATION DEVICE TIERED-THERAPY CARDIOVERTER/DEFIBRILLATOR

Philippines flagPhilippines·Abbott Medical (Singapore), Pte. Ltd. - Singapore mfd. By: St. Jude Medical Operations (M) Sdn. Bhd. - Penang, Malaysia For St. Jude Medical Cardiac Rhythm Management Division - CA, USA·USA·Issued July 09, 2021 – November 29, 2025
Device information
Product Name
UNIFY ASSURA™ CARDIAC RESYNCHRONIZATION DEVICE TIERED-THERAPY CARDIOVERTER/DEFIBRILLATOR
Registration Number
MDR-09002B
Manufacturer details
Country of Origin
USA
Importer & distribution
Importer/Distributor
Biodevices, Inc.
Registration dates
Issuance Date
July 09, 2021
Expiry Date
November 29, 2025
About this record

Access comprehensive regulatory information for UNIFY ASSURA™ CARDIAC RESYNCHRONIZATION DEVICE TIERED-THERAPY CARDIOVERTER/DEFIBRILLATOR in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-09002B and manufactured by Abbott Medical (Singapore), Pte. Ltd. - Singapore mfd. By: St. Jude Medical Operations (M) Sdn. Bhd. - Penang, Malaysia For St. Jude Medical Cardiac Rhythm Management Division - CA, USA in USA. The device was registered on July 09, 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.

Free DatabasePowered by Pure Global AIFDA Official DataUSA