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Biotronik Intica Neo Implantable Cardioverter Defibrillator - HSA Registration DE0504550

Access comprehensive regulatory information for Biotronik Intica Neo Implantable Cardioverter Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504550 and owned by BIOTRONIK SE & Co. KG. The device was registered on June 04, 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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CLASS D
DE0504550
Biotronik Intica Neo Implantable Cardioverter Defibrillator
HSA Registration Number: DE0504550
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Product Description

are intended to treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0504550
Registration Date
June 04, 2020
Change Notification Approval Date
March 18, 2024
Retention Due Date
June 03, 2025
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)
Torque Wrench BS DF-1 BS IS-1 BS IS-1 BS DF-1 Torque Wrench BS IS4 BS IS4 Intica Neo 5 VR-T DX Intica Neo 7 HF-T QP Intica Neo 7 HF-T Intica Neo 7 DR-T Intica Neo 7 VR-T DX Intica Neo 7 VR-T Intica Neo 5 HF-T QP Intica Neo 5 HF-T Intica neo 5 DR-T Intica Neo 5 VR-T
Model Identifier(s)
108984 119602 330834 395081 395082 395121 403724 403725 420569 429552 429553 429558 429559 429560 429566 429567 429568 429570