Australia TGA ARTG record

RYTHMIC EVOLUTION - Infusion pump, general-purpose

Australia TGA ARTG Registered Device · BTC Speciality Health Pty Ltd · Micrel Medical Devices SA · Class IIb · Started November 17, 2023

Good Name: BTC Speciality Health Pty Ltd - RYTHMIC EVOLUTION - Infusion pump, general-purpose

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: November 17, 2023
Effective Date: November 17, 2023

Sponsor

Name: BTC Speciality Health Pty Ltd

Manufacturer

Name: Micrel Medical Devices SA
Country: Greece
Address: 42 Konstantinoupoleos str Koropi, Athens, Greece, 19441

Intended purpose

Infusion pump system intended to support intravenous, intra-arterial, subcutaneous, or intraperitoneal administration of medicine, and may be used in close proximity to nerves, into an intraoperative site (soft tissue, body cavity /surgical wound site), epidural space, or subarachnoid space. This is a reusable device.

About this record

Access comprehensive regulatory information for RYTHMIC EVOLUTION - Infusion pump, general-purpose in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by BTC Speciality Health Pty Ltd, manufactured by Micrel Medical Devices SA in Greece. The device registration started on November 17, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.