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BIOTRONIK EDORA PACEMAKERS - HSA Registration DE0509134

Access comprehensive regulatory information for BIOTRONIK EDORA PACEMAKERS in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509134 and owned by BIOTRONIK SE & Co. KG. The device was registered on April 04, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0509134
BIOTRONIK EDORA PACEMAKERS
HSA Registration Number: DE0509134
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Product Description

Is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective: Compensation of bradycardia by atrial, ventricular, or AV sequential pacing; Additional triple-chamber features: Resynchronization of ventricular chamber contraction via biventricular pacing

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0509134
Registration Date
April 04, 2024
Retention Due Date
April 03, 2026
Product Owner
Short Name
BIOTRONIK SE & Co. KG
Address
Woermannkehre 1, 12359 Berlin, GERMANY
Registrant
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Model Information
Model Name(s)
Edora 8 HF-T QP Edora 8 HF-T Edora 8 DR-T Edora 8 DR Edora 8 SR-T Edora 8 SR
Model Identifier(s)
407137 407138 407145 407152 407157 407164