Philippines FDA registration MDR-00800

ISOFLEX™ OPTIM 1948 LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Philippines flagPhilippines·St. Jude Medical (Singapore) Pte. Ltd.·Singapore·Issued August 31, 2018 – August 28, 2023
Device information
Product Name
ISOFLEX™ OPTIM 1948 LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Registration Number
MDR-00800
Manufacturer details
Country of Origin
Singapore
Importer & distribution
Importer/Distributor
Biodevices Inc.
Registration dates
Issuance Date
August 31, 2018
Expiry Date
August 28, 2023
About this record

Access comprehensive regulatory information for ISOFLEX™ OPTIM 1948 LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-00800 and manufactured by St. Jude Medical (Singapore) Pte. Ltd. in Singapore. The device was registered on August 31, 2018.

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.

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