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YUKON MEDICAL, LLC.

USA · Durham

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, 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 1Class II 3Class III 0

plus 12 registration records and 11 510(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

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class Is (sterile) 1

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 States12 registration records, 11 510(k), 0 PMA

Manufacturer names merged into this page: Yukon Medical, LLC · YUKON MEDICAL, LLC.

FDA 510(k) clearances by year

32012

12013

12015

32017

12021

12024

12025

FDA listed device types

Set, I.V. Fluid Transfer 1Set, Administration, Intravascular 1Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1Applicator, Absorbent Tipped, Sterile 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240761	Arisure® Closed Male Luer with Spike Adapter (YM060)	2025-03-21
US	K243486	SmartSiteTM Vented Vial Access Device	2024-12-06
US	K201422	Arisure Closed System Drug Transfer Device (CSTD)	2021-03-02

YUKON MEDICAL, LLC.

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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