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Serim Research Corporation

USA · Elkhart

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Australia — 3 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

10listed device types

Class I 2Class II 8Class III 0

plus 15 registration records and 31 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

Class I 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States15 registration records, 31 510(k), 0 PMA

Saudi Arabia4 confirmed, 0 excluded

Manufacturer names merged into this page: SERIM RESEARCH CORP. · Serim Research Corp. · Serim Research Corporation

FDA 510(k) clearances by year

21990

41991

21992

21994

31995

11997

21999

12000

12001

12002

22005

32008

12009

12010

12012

22020

12025

12026

FDA listed device types

showing 8 of 10

Subsystem, Water Purification 1Indicator, Physical/Chemical Sterilization Process 1Sterilant, Medical Devices 1Filter, Blood, Dialysis 1Strip, Test, Reagent, Residuals For Dialysate, Disinfectant 1Detector, Leak, Blood 1Dialyzer Reprocessing System 1Strip, Dialysate Ph Indicator 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253863	GUARDIAN Quick Dip Residual Chlorine (5212)	2026-03-17
US	K251035	DISINTEK PA Test Strips	2025-06-03
US	K202565	WAVICIDE-OPA MEC Indicator	2020-12-02
SA	ME0000014350SFDAA00013	PINNACLE Monitor for Manual Enzymatic Cleaning Process	—
SA	ME0000014350SFDAA00012	PINNACLE Monitor for Automated Enzymatic Cleaning Process	—

Serim Research Corporation

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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