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EUDAMED registration 09332017000041No

Disposable Sterile Cardiac Blanket

Care Essentials Pty LtdClass IEU EUDAMEDTrade name: Cocoon
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
T030301
Trade name
Cocoon
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
09332017000041
Basic UDI
09332017CLM1ES
Active status
No
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
Name
Advena Limited
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
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

AIR FLOW BLANKETS

About this record

Access comprehensive regulatory information for Disposable Sterile Cardiac Blanket in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 09332017000041 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.