Singapore HSA registration DE0509134
BIOTRONIK EDORA PACEMAKERS
Singapore·CLASS D·BIOTRONIK SE & Co. KG·Registered April 04, 2024Device 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 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
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
About this record
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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