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Breast and Perineum Ice/heat gel pack - Compress, hot/cold pack, reusable

Access comprehensive regulatory information for Breast and Perineum Ice/heat gel pack - Compress, hot/cold pack, reusable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Bubba Bump, manufactured by Jiangsu Ningshangyou Daily Commodity Co Ltd in China. The device registration started on September 03, 2021.

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.

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TGA ARTG Official Data
Class I
Class I
Breast and Perineum Ice/heat gel pack - Compress, hot/cold pack, reusable
Australia TGA ARTG Registered Device
Good Name: Bubba Bump - Breast and Perineum Ice/heat gel pack - Compress, hot/cold pack, reusable
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Intended Purpose

Hot/cold therapy pack, reusable A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 03, 2021
Effective Date
September 03, 2021
Sponsor
Manufacturer
Country
China
Address
2nd Floor No 21 Building Caimao Industry and Trading Town Sucheng District, Suqian City, Jiangsu, 223800