Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011139154

FEI Number

3011139154

Entity Name

Uzinmedicare Co., Ltd.

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

54, 56, 60 Dongtansandan 5-gil, Hwaseong-si Gyeonggi 18487, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Uzinmedicare Co., Ltd. (Owner Number: 10033747)

Owner / Operator Contact Address

56, Dongtansandan 5-gil, Hwaseong-si, KR-41 18487, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162415

PMA Number

N/A

All Registered Proprietary Names

Spectra SG Portable UV-Sterilizers (for baby bottle), Model : Spectra Model : Spectra UV-Sterilizers (for baby bottle) Spectra Q Spectra Handy Plus Spectra wide manual pump Spectra Handy Spectra Wearable2 Spectra S2 Pro Spectra S1 Pro Spectra Platinum SPECTRA WEARABLE Spectra 9plus

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	2021-12-16
MCF	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile	Dental	Class 1	872.6855	2017-08-18
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-02-14
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2017-04-27
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-04-07
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2026-02-10
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2025-12-14
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2022-12-21
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2017-05-14

Official Correspondent

Byungwook Min

US Agent Details

Heidi Humphries Email: hprn@aol.com Phone: (954) 4714429

Related Public Records

Same Entity

Uzinmedicare Co., Ltd.

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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3043515178	INTERFOCUS INC.	Mountain View, CA, US
3043165985	CHAFON TECHNOLOGY CO., LIMITED	TSIM SHA TSUI Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011139154. Last updated year: 2026. Please use registration number 3011139154 when referencing this establishment in official correspondence.