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Singapore HSA registration DE0504686

BIOTRONIK ENITRA PACEMAKERS

Singapore flagSingapore·CLASS D·BIOTRONIK SE & Co. KG·Registered July 13, 2020
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0504686
Registration Date
July 13, 2020
Change Notification Approval Date
January 29, 2024
Retention Due Date
July 12, 2025
Product description
Enitra 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: (1) Compensation of bradycardia by atrial, ventricular, or AV sequential pacing. (2) Additional triple-chamber features: Resynchronization of ventricular chamber contraction via biventricular pacing.
Product Owner
Name
BIOTRONIK SE & Co. KG
Short Name
BIOTRONIK SE & Co. KG
Address
Woermannkehre 1, 12359 Berlin, GERMANY
Registrant
Name
BIOTRONIK ASIA PACIFIC PTE. LTD.
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Importer
Name
BIOTRONIK ASIA PACIFIC PTE. LTD.
Address
165 KALLANG WAY, #07-00, SINGAPORE 349257
Model information
Model Name(s)
Torque wrench TW BS IS-1 BS IS4 Enitra 8 HF-T QP Enitra 8 HF-T Enitra 8 DR-T Enitra 6 DR-T Enitra 6 DR Enitra 8 SR-T Enitra 6 SR-T Enitra 6 SR
Model Identifier(s)
108984 330834 403724 407141 407142 407147 407150 407153 407159 407162 407165
About this record

Access comprehensive regulatory information for BIOTRONIK ENITRA 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 DE0504686 and owned by BIOTRONIK SE & Co. KG. The device was registered on July 13, 2020.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D