HomeAustraliaCare Essentials Pty Ltd

Care Essentials Pty Ltd

Australia · North Geelong Victoria · www.careessentials.com.au
✓ Record-verifiedregistrations found in 10 marketsEU SRN AU-MF-000009150

This company has registrations in European Union, United States, United Kingdom, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
126UDI-DI device records
Class I 121Class IIb 5
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 4 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class I 2Class IIb 1
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
8active ARTG entries
Class I 6IIb 1Class Is (sterile) 1
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union132 raw hits, 6 excluded, 126 confirmed
United States4 registration records, 4 510(k), 0 PMA, 4 excluded
United Kingdom3 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: CARE ESSENTIALS PTY LTD · CARE ESSENTIALS PTY LTD.

Regulatory identity

EU manufacturer SRN
AU-MF-000009150
EU authorised representative
Advena Limited
UK responsible person
Advena Ltd

Company information

Country
Australia
City
North Geelong Victoria
Website
www.careessentials.com.au
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systems

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

ABN
89148060486
Registration status
Active
Legal form
Australian Private Company
Registered address
VIC, 3215

Business registration data from Australian Business Register, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12014 · K140635
12019 · K181671
12022 · K213907
12024 · K232502

FDA listed device types

Wrap, Sterilization 1System, Thermal Regulating 1

Registration details (sample)

MarketIdentifierNameClass / date
EU09332017004100Cocoon Convective Warming System - CWS7000Class IIb
EU09332017004087Cocoon Convective Warming System - CWS 5000Class IIb
EU09332017004148Cocoon Surgical Access BlanketClass I
EU19332017001519CareGuardClass I
UK36954Cocoon Patient Warming MachineClass IIb
UK47682Cocoon Sterile BlanketClass I
UK47681Cocoon Cath LabClass I
USK232502Cocoon Convective Warming System, Model CWS70002024-02-21
USK213907CareGUARD Sterilization Wrap2022-03-14
USK181671Cocoon Convective Warming System2019-05-02

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