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Singapore HSA registration DE0504946

BIOTRONIK ENTICOS PACEMAKERS

Singapore flagSingapore·CLASS D·BIOTRONIK SE & Co. KG·Registered September 21, 2020
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0504946
Registration Date
September 21, 2020
Change Notification Approval Date
January 29, 2024
Retention Due Date
September 20, 2025
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
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 BS DF-1 BS IS-1 BS IS-4 Enticos 8 HF-T QP Enticos 8 HF-T Enticos 8 DR-T Enticos 4 DR Enticos 4 D Enticos 8 SR-T Enticos 4 SR Enticos 4 S
Model Identifier(s)
108984 119602 330834 403724 407143 407144 407148 407155 407156 407160 407167 407168
About this record

Access comprehensive regulatory information for BIOTRONIK ENTICOS 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 DE0504946 and owned by BIOTRONIK SE & Co. KG. The device was registered on September 21, 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.

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