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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 2 of 2

Device	Model / Reference	Registries	Class	Status
Paediatric Lower Body	CLM 0117	EUDAMEDFDA UDI	Class I	Active
Flexi Gown Blanket (Large)	CLM 0145L	EUDAMEDFDA UDI	Class I	Active
Cocoon Surgical Access Blanket	CLM 0124F	EUDAMED	Class I	Active
Adult Full Acess Underbody	CLM 0127	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW606060-B/W	EUDAMED	Class I	Active
Full Body - Large	CLM 0130	EUDAMEDFDA UDI	Class I	Active
Underbody Lithotomy	CLM 0137	EUDAMEDFDA UDI	Class I	Active
Lithotomy & Laparoscopy	CLM 0125	EUDAMEDFDA UDI	Class I	Active
Full Pre-Warming Gown Blanket Small (S) with Kit (Patient Belonging Bag, Cap, Booties)	CLM 099K	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW12012050-B/W	EUDAMED	Class I	Active
CareGuard	SW767675-B/B	EUDAMED	Class I	Active
CareGuard	SW919150-B	EUDAMED	Class I	Active
Gynaecology	CLM 0120	EUDAMEDFDA UDI	Class I	Active
Cocoon	CWS 5000	EUDAMEDFDA UDI	Class IIb	Active
Full Torso Bariatric	CLM 0128	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW919160-B/W	EUDAMED	Class I	Active
Cocoon Full Body	CLM 0101	EUDAMEDFDA UDI	Class I	Active
Multipurpose Hose Sock	CLM 0112	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW11611660-B	EUDAMED	Class I	Active
Cocoon Paediatric - Child	CLM 0107	EUDAMEDFDA UDI	Class I	Active
Cocoon Paediatric - Neonatal	CLM 0105	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW919175-B/B	EUDAMED	Class I	Active
CareGuard	SW13718260-B/B	EUDAMED	Class I	Active
Cath Lab Blanket	CLM 0113	EUDAMEDFDA UDI	Class I	Active
Full Pre-Warming Gown Blanket Small (S)	CLM 099	EUDAMEDFDA UDI	Class I	Active
Flexi Gown Blanket (Regular)	CLM 0145R	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW11611650-B/W	EUDAMED	Class I	Active
CareGuard	SW11611675-B	EUDAMED	Class I	Active
CareGuard	SW13718250-B/W	EUDAMED	Class I	Active
Flexi Gown Blanket (Small)	CLM 0145S	EUDAMEDFDA UDI	Class I	Active
CareGuard	SW767675-B	EUDAMED	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