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Singapore HSA registration DE0507259

BIOTRONIK Renamic Neo Medical Programmer and Monitoring Device

Singapore flagSingapore·CLASS C·BIOTRONIK SE & Co. KG·Registered September 14, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0507259
Registration Date
September 14, 2022
Change Notification Approval Date
July 22, 2024
Retention Due Date
September 13, 2025
Product description
The programmer provides communication with BIOTRONIK implantable pacemakers, ICDs, or implantable cardiac monitors (ICMs) during the implantation procedure or patient follow-up. The programmer is intended to enable the intended use of the implantable products by supplying the user interface to the device functions. Therefore, the programmer is used: to verify and optimize the therapy delivered by the devices; to support diagnosis of the patient status through data delivered by the devices. The PSA (pacing system analyzer) of the programmer supports lead implantations during the implantation procedure. Therefore, the PSA is used: to support lead implantations with intraoperative measurements of electrophysiological parameters.
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)
PA‑2 PK‑67-L PA‑1‑B PK-67-S PK‑222 EU PK‑155 PK Electrode Clip PA‑1‑C PK-141 Renamic Neo PK‑222‑L ECG cable
Model Identifier(s)
123157 123672 123751 128085 335284 337358 340293 349723 353181 424725 429747
About this record

Access comprehensive regulatory information for BIOTRONIK Renamic Neo Medical Programmer and Monitoring Device in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507259 and owned by BIOTRONIK SE & Co. KG. The device was registered on September 14, 2022.

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 C