Hygeia Ii Medical Group Inc

FDA Filings

This page includes the latest FDA filings for Hygeia Ii Medical Group Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3006774448
FEI Number	3006774448
Name	HYGEIA II MEDICAL GROUP, INC.
Owner & Operator	Hygeia II Medical Group, Inc.
Contact Address	6241 Yarrow Dr. Suite A Carlsbad CA 92011 US
Official Correspondent	Jean Piekarz x-714-5157571-201
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	6241 Yarrow Dr Ste A Carlsbad, CA 92011 US
Establishment Type	Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850013900336 HYGEIA II MEDICAL GROUP INC	Express Powered breast pump	2024-07-18
GUDID 00850013900305 HYGEIA II MEDICAL GROUP INC	FIT Pro	2023-08-09
PMN K200406 Hygeia II Medical Group, Inc.	Evolve Breast Pump	2020-03-18
GUDID 00865278000462 HYGEIA II MEDICAL GROUP INC	Evolve Breast Pump	2020-01-06
PMN K190465 Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
GUDID 00860001425284 HYGEIA II MEDICAL GROUP INC	Evolve Breast Pump	2019-07-01
GUDID 00860001425277 HYGEIA II MEDICAL GROUP INC	Evolve Breast Pump	2019-07-01
GUDID 00860001425260 HYGEIA II MEDICAL GROUP INC	Evolve	2019-07-01
GUDID 00860001425253 HYGEIA II MEDICAL GROUP INC	Evolve Breast Pump	2019-07-01
GUDID 00860001425246 HYGEIA II MEDICAL GROUP INC	Evolve Breast Pump	2019-07-01
GUDID 00860001425239 HYGEIA II MEDICAL GROUP INC	Evolve	2019-07-01
GUDID 00865278000486 HYGEIA II MEDICAL GROUP INC	Evolve Breast Pump, PAS	2018-08-06
GUDID 00865278000479 HYGEIA II MEDICAL GROUP INC	Evolve Breast Pump	2018-08-06
GUDID 00865278000417 HYGEIA II MEDICAL GROUP INC	EnJoye Metal Luer lock	2018-07-06
GUDID 00865278000400 HYGEIA II MEDICAL GROUP INC	EnJoye Cordless Metal Luer Lock	2018-07-06
HGY HYGEIA II MEDICAL GROUP, INC.	Hygeia 2 Hand Manual Breast Pump	2011-02-18
HGY HYGEIA II MEDICAL GROUP, INC.	EnHande Manual Breast Pump	2011-02-18
PMN K081932 \| HGX HYGEIA II MEDICAL GROUP, INC.	Q	2009-02-12
PMN K081932 \| HGX HYGEIA II MEDICAL GROUP, INC.	EnRiche	2009-02-12
PMN K081932 \| HGX HYGEIA II MEDICAL GROUP, INC.	EnJoye	2009-02-12
PMN K081932 \| HGX HYGEIA II MEDICAL GROUP, INC.	EnDeare	2009-02-12

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020072951311	Hong Kong,Hong Kong -> Long Beach, California	UNIVERSAL DELUXE PAS P N 20 0075 REF 657 HTS CODE 3924 90 5650 TUBING FOR BREAST PUMP 2 PACK P N 20 0084 REF 777	230 CTN
2020061038636	Hong Kong,Hong Kong -> Long Beach, California	BREAST PUMP P N 10 0026 302SET REF 573 HTS CODE 9903 88 06 BASE TOTE REV AB P N 50 0094 REF 655	211 CTN
2020061024383	Hong Kong,Hong Kong -> Long Beach, California	BREAST PUMP P N 10 0026 1000SET REF 573 HTS CODE 9903 88 06 DELUXE TOTES COOLER BAG CHANGING PAD REV AC P N 50 0039 REF 655	545 CTN
2020060628697	Hong Kong,Hong Kong -> Long Beach, California	BREAST PUMP P N 10 0026 1000SET REF 573 HTS CODE 9903 88 06 DELUXE TOTES COOLER BAG CHANGING PAD REV AC P N 50 0039 REF 655	545 CTN
2020060639466	Hong Kong,Hong Kong -> Long Beach, California	BREAST PUMP P N 10 0026 302SET REF 573 HTS CODE 9903 88 06 BASE TOTE REV AB P N 50 0094 REF 655	211 CTN
2020060438111	Hong Kong,Hong Kong -> Long Beach, California	BREAST PUMP P N 10 0026 1000SET REF 573 HTS CODE 9903 88 06 DELUXE TOTES COOLER BAG CHANGING PAD REV AC P N 50 0039 REF 655	545 CTN
2020060456359	Hong Kong,Hong Kong -> Long Beach, California	BREAST PUMP P N 10 0026 302SET REF 573 HTS CODE 9903 88 06 BASE TOTE REV AB P N 50 0094 REF 655	211 CTN
2020060230512	Hong Kong,Hong Kong -> Long Beach, California	BREAST PUMP P N 10 0026 302SET REF 573 HTS CODE 9903 88 06 BASE TOTE REV AB P N 50 0094 REF 655	211 CTN