Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021635975

FEI Number

3021635975

Entity Name

HUBDIC USA INC

City/State/Country

Carson, CA, US

Establishment Address

129 Savarona Way, Carson, CA 90746, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

HuBDIC USA INC (Owner Number: 10084344)

Owner / Operator Contact Address

129 Savarona way, Carson, CA 90746, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HuBDIC HubiBaby HuBDIC HuBDIC HuBDIC HubiBaby UV-C baby bottle sterilizer and dryer HNA-3000 HNA-300 HNA-150 HNA-20 HuBDIC HNA-1000 HNA-500 HNA-1000Y HNA-3000Y HNA-3000G BT-200 MD-100 HEM-5 FE-7207 FE-0161 HMH-1000 FE-7208 HGM-100 HMG-300 FE-7301 FE-4601 HNA-300 HNA-500 HubiBaby HNA-3000 HNA-150 HubiBaby HNA-3000Y HubiBaby HNA-3000G HuBDIC HNA-1000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-03-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-02-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-07-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-09-26
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-10-27
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-04-23
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2024-01-09
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2025-06-05
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2025-06-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2022-10-27
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-12-10

Official Correspondent

Kevin Chung

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HuBDIC USA 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021635975. Last updated year: 2026. Please use registration number 3021635975 when referencing this establishment in official correspondence.