HYGEIA II MEDICAL GROUP, INC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3006774448

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006774448
FEI Number
3006774448
Entity Name
HYGEIA II MEDICAL GROUP, INC.
City/State/Country
Carlsbad, CA, US
Establishment Address
6241 Yarrow Dr Ste A, Carlsbad, CA 92011, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Hygeia II Medical Group, Inc. (Owner Number: 10025094)
Owner / Operator Contact Address
6241 Yarrow Dr., Suite A, Carlsbad, CA 92011, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K212955
PMA Number
N/A

All Registered Proprietary Names

EnHande Manual Breast Pump Hygeia 2 Hand Manual Breast Pump EVOLVE Nova Luxe Q EnRiche EnJoye EnDeare Hygeia FIT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HGY Pump, Breast, Non-Powered Obstetrics/Gynecology Class 1 884.5150 2011-02-18
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2020-05-04
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2026-01-08
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2009-02-12
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2023-08-01
HGX Pump, Breast, Powered Obstetrics/Gynecology Class 2 884.5160 2022-03-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hygeia II Medical Group, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190465 Hygeia II Medical Group, Inc. Evolve Breast Pump 2019-10-18
K021739 Limerick, Inc. LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006774448. Last updated year: 2026. Please use registration number 3006774448 when referencing this establishment in official correspondence.
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