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MedSource Labs, LLC

USA · Chanhassen

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

65listed device types

Class I 43Class II 21Class III 0unclassified 1

plus 76 registration records and 3 510(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

17active device licences

Class II 17

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States76 registration records, 3 510(k), 0 PMA, 6 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: MedSource Labs, LLC · MEDSOURCE LABS, LLC DBA MEDSOURCE INTERNATIONAL, LLC

Same-named companies — This database also contains companies with near-identical names: MEDSOURCE LABS, LLC DBA MEDSOURCE INTERNATIONAL, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12020 · K193278

22026 · K261041

FDA listed device types

showing 8 of 65

Stretcher, Hand-Carried 1Mouthpiece, Breathing 1Scissors, Medical, Disposable 1Mask, Oxygen, Non-Rebreathing 1Regulator, Pressure, Gas Cylinder 1Splint, Hand, And Components 1Stretcher, Patient Restraint 1Needle, Aspiration And Injection, Disposable 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261041	ClearSafe Closed System	2026-07-10
US	K260539	MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter	2026-07-09
US	K193278	MedSource CathMED IV Catheter	2020-08-07
CA	90235	NASAL CANNULA	Class II
CA	90236	I.V. SAFETY CATHETER	Class II
CA	90237	LARYNGOSCOPE BLADES	Class II

MedSource Labs, 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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