Singapore HSA registration DE0505601
BIOTRONIK CardioMessenger Smart 4G Transmitter
Singapore·CLASS C·BIOTRONIK SE & Co. KG·Registered March 29, 2021Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0505601
- Registration Date
- March 29, 2021
- Change Notification Approval Date
- November 09, 2023
- Retention Due Date
- March 28, 2026
Product description
The CardioMessenger Smart is a data transmitter. The use of the CardioMessenger Smart is necessary for a patient who carries a BIOTRONIK implantable device with Home Monitoring function to receive medical care via telemedicine. The CardioMessenger Smart is a part of the telemetry chain of the BIOTRONIK Home Monitoring System. It relays data between the implanted device and the Home Monitoring Service Center. The CardioMessenger Smart receives data from the implant and transmits it to the BIOTRONIK Home Monitoring Service Center via the GSM Network. The CardioMessenger Smart is classified as an accessory of the implanted device and has no diagnostic or therapeutic function itself. Its use is indicated whenever remote monitoring for the diagnosis and monitoring of the patient’s cardiac disease or the implanted device is deemed necessary or advantageous by the physician or suggested by the applicable guidelines.
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)
- CardioMessenger Smart 4G GlobTek GTM96180 CE
- Model Identifier(s)
- 438617 444207
About this record
Access comprehensive regulatory information for BIOTRONIK CardioMessenger Smart 4G Transmitter in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505601 and owned by BIOTRONIK SE & Co. KG. The device was registered on March 29, 2021.
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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