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Singapore HSA registration DE0504550

Biotronik Intica Neo Implantable Cardioverter Defibrillator

Singapore flagSingapore·CLASS D·BIOTRONIK SE & Co. KG·Registered June 04, 2020
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 description
are intended to treat life-threatening ventricular arrhythmias with antitachycardia pacing and defibrillation
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-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
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D