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KORU MEDICAL SYSTEMS, INC.

USA · Mahwah

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Australia, Hong Kong, Israel — 6 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

3listed device types

Class I 0Class II 3Class III 0

plus 10 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

4 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

1valid listings

Class II 1

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 States10 registration records, 5 510(k), 0 PMA

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: KORU MEDICAL SYSTEMS, INC. · KORU MEDICAL SYSTEMS INC.

Same-named companies — This database also contains companies with near-identical names: Repro-Med Systems, Inc. Dba Koru Medical Systems, Repro-Medical System, Inc., Dba Koru Medical Systems. Company name alone cannot separate their registrations, so the figures below may include either.

Business registration

CIK: 0000704440
Registration status: Active
Listing status: Listed (KRMD)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252015	FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing	2026-01-28
US	K231918	Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter	2023-11-03
US	K214045	FreedomEdge Syringe Infusion System	2022-04-29
CA	79676	RES-Q-VAC HAND HELD MEDICAL SUCTION KITS	Class II
CA	79807	RES-Q-VAC HAND HELD MEDICAL SUCTION CATHETERS	Class II
CA	79808	RES-Q-VAC HAND HELD MEDICAL SUCTION REPLACEMENT KITS	Class II

KORU MEDICAL SYSTEMS, INC.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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