EUDAMED registration 09332017000553YesConvective Patient Warming Machine
- Risk class
- Class IIb
- CND nomenclatures code
- Z12040208
- Trade name
- Cocoon
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 09332017000553
- Basic UDI
- 09332017CWS4H9
- Active status
- Yes
- Manufacturer name
- Care Essentials Pty Ltd
- Country
- Australia
- Country type
- NON_EU
- Address
- 103 Mornington Street North Geelong, Victoria
- queries@careessentials.com.au
- Name
- Advena Limited
- SRN
- MT-AR-000000234
- Country
- Malta
- Address
- Tower Street Swatar
- prrc@advena.mt
- Competent authority
- Malta Medicines Authority
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Bulgaria
- Market available
- Austria:2024-12-12~None, Belgium:2024-12-12~None, Bulgaria:2024-12-12~None, France:2024-12-12~None, Germany:2024-12-12~None, Italy:2024-12-12~None, Netherlands:2024-12-12~None, Norway:2024-12-12~None, Portugal:2024-12-12~None, Spain:2024-12-12~None
- Human tissues
- No
- Animal tissues
- No
BODY THERMOREGULATION EQUIPMENT
Access comprehensive regulatory information for Convective Patient Warming Machine in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 09332017000553 and manufactured by Care Essentials Pty Ltd in Australia.
This page provides complete registration details including trade name (Cocoon), manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.