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Convective Patient Warming Machine - EUDAMED Registration 09332017000553

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.

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EUDAMED Official Data
Class IIb
09332017000553
Yes
Convective Patient Warming Machine
Trade Name: Cocoon
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Device Description (EMDN)

BODY THERMOREGULATION EQUIPMENT

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z12040208
Trade Name
Cocoon
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09332017000553
Basic UDI
09332017CWS4H9
Active Status
Yes
Manufacturer
Manufacturer Name
Care Essentials Pty Ltd
Country
Australia
Country Type
NON_EU
Address
103 Mornington Street North Geelong, Victoria
Email
queries@careessentials.com.au
Authorized Representative
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No