HomeUSAMEDSOURCE LABS, LLC DBA MEDSOURCE INTERNATIONAL, LLC

MEDSOURCE LABS, LLC DBA MEDSOURCE INTERNATIONAL, LLC

USA · Chanhassen
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
65listed device types
Class I 43Class II 21Class III 0unclassified 1
plus 76 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
18registered devices
Class II 18
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
62registered 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, 13 510(k), 0 PMA, 4 excluded
Brazil18 confirmed, 0 excluded
Saudi Arabia62 confirmed, 1 excluded
Canada17 confirmed, 0 excluded
Manufacturer names merged into this page: MedSource Labs, LLC · MEDSOURCE LABS, LLC DBA MEDSOURCE INTERNATIONAL, LLC · MEDSOURCE INTERNATIONAL, LLC · MEDSOURCE INTERNATIONAL LLC
Same-named companies — This database also contains companies with near-identical names: MedSource Labs, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Chanhassen

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

22008
12012
32014
22015
12016
12020
12023
22026

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)

MarketIdentifierNameClass / date
USK261041ClearSafe Closed System2026-07-10
USK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter2026-07-09
USK223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter2023-09-15
BR81325999070Cateter IV padrão VeroTrue®Class II
BR81325999071Cateter IV de segurança Pursafe®Class II
BR81325999012Clearsafe Comfort Safety I.V CatheterClass II
SAME0000001066SFDAA00039Basket Stretcher
SAME0000001066SFDAA00040Air Splint Set Orange
CA90235NASAL CANNULAClass II
CA90236I.V. SAFETY CATHETERClass II
CA90237LARYNGOSCOPE BLADESClass II

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