Data / Medical devices / South Korea / Uzinmedicare Co., Ltd.

Uzinmedicare Co., Ltd.: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 11 510(k) clearances

Name: Uzinmedicare Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Uzinmedicare Co., Ltd. is registered with the FDA (registration 3011139154) in Hwaseong-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 6, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011139154
Address: 54, 56, 60 Dongtansandan 5-gil, Hwaseong-si Gyeonggi, South Korea, 18487
Owner or operator: Uzinmedicare Co., Ltd. (10033747)
Roles: Manufacturer, Specification developer
First device listed: September 27, 2010
Registered through: 2026
Brand names listed: Clinicare Dew400, Model : Spectra, SPECTRA WEARABLE, Spectra 9plus, Spectra Dew300, Spectra Dew350, Spectra Handsfree Breast Shield Set 2, Spectra Handy and more

Devices it lists

Device	Product code	Class	Role	Source
Breast Pump Kit	OHH	2	Manufacturer, Specification developer	accessdata.fda.gov
Pump, Breast, Non-Powered	HGY	1	Manufacturer	accessdata.fda.gov
Pump, Breast, Powered	HGX	2	Manufacturer	accessdata.fda.gov
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile	MCF	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 6, 2026	K250208	SPECTRA Wearable 2	HGX	Substantially Equivalent	Uzinmedicare Co., Ltd.	accessdata.fda.gov
February 6, 2026	K251423	Spectra S1 Pro; Spectra S2 Pro	HGX	Substantially Equivalent	Uzinmedicare Co., Ltd.	accessdata.fda.gov
November 25, 2025	K251932	Spectra Platinum	HGX	Substantially Equivalent	Uzinmedicare Co., Ltd.	accessdata.fda.gov
December 12, 2022	K220926	Spectra Wearable	HGX	Substantially Equivalent	Uzinmedicare Co., Ltd.	accessdata.fda.gov
October 19, 2021	K210124	Synergy Gold (SG) Portable (Models MM011450 and MM011460)	HGX	Substantially Equivalent	Uzinmedicare Co.	accessdata.fda.gov
January 22, 2020	K191109	Spectra Q	HGX	Substantially Equivalent	Uzinmedicare Co.	accessdata.fda.gov
October 11, 2019	K191208	Spectra Cashmere	HGX	Substantially Equivalent	Uzinmedicare Co.	accessdata.fda.gov
November 30, 2018	K181784	Spectra S3 Plus	HGX	Substantially Equivalent	Uzinmedicare Co.	accessdata.fda.gov
March 15, 2017	K162415	Spectra 9Plus	HGX	Substantially Equivalent	Uzinmedicare Company	accessdata.fda.gov
April 15, 2016	K150476	Spectra S1Plus and Spectra S2 Plus	HGX	Substantially Equivalent	Uzinmedicare Co.	accessdata.fda.gov
August 13, 2010	K093145	SPECTRA SERIES BREAST PUMP	HGX	Substantially Equivalent	Uzinmedicare Co.	accessdata.fda.gov

Compare with other makers

Updated April 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.