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CARE ESSENTIALS PTY LTD

Australia·AU-MF-000009150

Last updated September 17, 2026

Information

Country: Australia
Address: 103 Mornington Street, North Geelong, Victoria, Australia
Website: www.careessentials.com.au
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +61 3 52771455
PRRC Contact: Ishan Sinha
EUDAMED SRN: AU-MF-000009150
FDA FEI Number: 3011059079
DUNS Number: —

Catalogue (81)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Full Pre-Warming Gown Blanket Large (L)	CLM 097	EUDAMEDFDA UDI	Class I	Active
Cocoon Upper Body - Arms Out	CLM 0104	EUDAMEDFDA UDI	Class I	Active
Paediatric Full Body	CLM 0109	EUDAMEDFDA UDI	Class I	Active
Extended Upper Torso - Arms In	CLM 0131	EUDAMEDFDA UDI	Class I	Active
Full Pre-Warming Gown Blanket Extra Large with Kit (Patient Belonging Bag, Cap, Booties)	CLM 096K	EUDAMEDFDA UDI	Class I	Active
Full Pre-Warming Gown Blanket Large (L) with Kit (Patient Belonging Bag, Cap, Booties)	CLM 097K	EUDAMEDFDA UDI	Class I	Active
Cocoon Convective Warming System, Model CWS7000	K232502	FDA 510(k)	Class II	Active
CareGUARD Sterilization Wrap	K213907	FDA 510(k)	Class II	Active
CareGuard	SW919150-B/W	EUDAMED	Class I	Active
CareGuard	SW13718275-B	EUDAMED	Class I	Active
Small Paediatric Underbody	CLM 0116	EUDAMEDFDA UDI	Class I	Active
Flexi Gown Blanket (Large)	CLM 0145L-K	EUDAMEDFDA UDI	Class I	Active
Cocoon Cardiac Access	CLM 0108	EUDAMEDFDA UDI	Class I	Active
Large Adult Underbody	CLM 0138	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW13713775-B/W	EUDAMED	Class I	Active
CareGuard	SW767650-B/W	EUDAMED	Class I	Active
Cocoon Paediatric - Neonatal	CLM 0105L	EUDAMEDFDA UDI	Class I	Active
Flexi Gown Blanket (Small)	CLM 0145S-K	EUDAMEDFDA UDI	Class I	Active
Cocoon Convective Warming System - CWS 5000	CWS5000-220	EUDAMEDFDA UDI	Class IIb	Active
CareGuard	SW11611660-B/B	EUDAMED	Class I	Active
Full Pre-Warming Gown Blanket Extra Large	CLM 096	EUDAMEDFDA UDI	Class I	Active
Extended Upper Torso - Arms Out	CLM 0132	EUDAMEDFDA UDI	Class I	Active
Cocoon	CWS 4000	EUDAMEDFDA UDI	Class IIb	Active
Full Pre-Warming Gown Blanket Medium with Kit (Patient Belonging Bag, Cap, Booties)	CLM 098K	EUDAMEDFDA UDI	Class I	Active
Surgical Access	CLM 0124	EUDAMEDFDA UDI	Class I	Active
Full Pre-Warming Gown Blanket Medium (M)	CLM 098	EUDAMEDFDA UDI	Class I	Active
Extended Lower Body	CLM 0129	EUDAMEDFDA UDI	Class I	Active
Underbody Spinal Blanket	CLM 0133	EUDAMEDFDA UDI	Class I	Active
Flexi Gown Blanket (Regular)	CLM 0145R-K	EUDAMEDFDA UDI	Class I	Active
Wide Cardiac	CLM 0141	EUDAMEDFDA UDI	Class I	Active
Paediatric - Child Extended	CLM 0147	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW606050-B/W	EUDAMED	Class I	Active
Bariatric Blanket	CLM 0126	EUDAMEDFDA UDI	Class I	Active
Large Paediatric Underbody	CLM 0115	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW606075-B	EUDAMED	Class I	Active
CareGuard	SW13713750-B/B	EUDAMED	Class I	Active
Adult tube	CLM 0122	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW13718250-B	EUDAMED	Class I	Active
Cocoon Lower Body	CLM 0102	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW606075-B/W	EUDAMED	Class I	Active
CareGuard	SW10010075-B/B	EUDAMED	Class I	Active
Multi Access	CLM 0121	EUDAMEDFDA UDI	Class I	Active
Cocoon Paediatric - Tube	CLM 0106	EUDAMEDFDA UDI	Class I	Active
Cocoon Upper Body - Arms In	CLM 0103	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW13713775-B	EUDAMED	Class I	Active
CareGuard	SW919150-B/B	EUDAMED	Class I	Active
Cocoon Convective Warming System - CWS 4000	CWS4000-220	EUDAMED	Class IIb	Active
CareGuard	SW12012050-B/B	EUDAMED	Class I	Active
CareGuard	SW10010075-B/W	EUDAMED	Class I	Active
Abdominal Access	CLM 0118	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 7, 2020	Z-0986-2020	—	terminated	Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
Jan 7, 2020	Z-0987-2020	—	terminated	Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Care Essentials Pty Ltd US