HomeUSAMedsource International, LLC

Medsource International, LLC

USA · Mound
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia — 5 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
10510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 10 510(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
6active ARTG entries
Class I 6
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 States0 registration records, 10 510(k), 0 PMA, 7 excluded
Brazil18 confirmed, 0 excluded
Saudi Arabia62 confirmed, 1 excluded
Canada17 confirmed, 0 excluded
Manufacturer names merged into this page: MEDSOURCE LABS, LLC DBA MEDSOURCE INTERNATIONAL, LLC · MEDSOURCE INTERNATIONAL, LLC · MEDSOURCE INTERNATIONAL LLC

Company information

Country
USA
City
Mound

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 · K120424
32014 · K140442
22015 · K150611
12016 · K161779
12023 · K223788

Registration details (sample)

MarketIdentifierNameClass / date
USK223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter2023-09-15
USK161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter2016-11-03
USK150611MedSource ClearSafe Safety IV Catheter2015-07-15
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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