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Uzinmedicare Co., Ltd.

Korea, Republic · Hwaseong-Si

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Canada, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 2Class II 2Class III 0

plus 14 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States14 registration records, 12 510(k), 0 PMA

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: Uzinmedicare Co., Ltd. · UZINMEDICARE CO., LTD · UZINMEDICARE CO.

FDA 510(k) clearances by year

12010

12016

12017

12018

12019

12020

12021

12022

12025

32026

FDA listed device types

Pump, Breast, Powered 1Breast Pump Kit 1Pump, Breast, Non-Powered 1Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260956	Spectra Platinum Mini	2026-06-04
US	K250208	SPECTRA Wearable 2	2026-04-06
US	K251423	Spectra S1 Pro; Spectra S2 Pro	2026-02-06
SA	ME0000000172SFDAA00007	Spectra Handy Plus	—
SA	ME0000000172SFDAA00004	Spectra UV sterilizer	—

Uzinmedicare Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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