G Care Electronics L T D

FDA Filings

This page includes the latest FDA filings for G Care Electronics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3011533696

FEI Number

3011533696

Name

G-CARE ELECTRONICS LTD

Owner & Operator

G-Care Electronics Ltd

Contact Address

Knockmore Hill Business Park 9 Ferguson Drive
Lisburn GB-ANT Antrim BT28 2EX GB

Official Correspondent

Maria G McGrady
044-28-92660-118

US Agent

Kyle Rose
Ortek Therapeutics Inc
404 7179358
kyle.rose@rookqs.com

Importing Logistics Registration

Importer	ORTEK THERAPEUTICS, INC
Address	4 Expressway Plaza Roslyn Heights Roslyn Heights, NY 11577 UNITED STATES

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

Knockmore Hill Business Park 9 Ferguson Drive
Lisburn Antrim, BT28 2EX GB

Establishment Type

Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K170822 \| NBL G-CARE ELECTRONICS LTD	Ortek ECD	2020-01-30
PMN K170822 \| LFC G-CARE ELECTRONICS LTD	Ortek ECD	2020-01-30
PMN K161885 \| OUP G-CARE ELECTRONICS LTD	Cellfina System	2016-11-07
PMN K153677 \| OUP G-CARE ELECTRONICS LTD	The Cellfina System	2016-07-15