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Mozarc Medical Us, LLC

USA · Mansfield
✓ 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
17listed device types
Class I 1Class II 16Class III 0
plus 46 registration records and 1 510(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
2active device licences
Class III 1Class IV 1
18 including historic records
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 States46 registration records, 1 510(k), 0 PMA, 1 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: MOZARC MEDICAL US LLC · MOZARC MEDICAL US LLC DBA COVIDIEN LLC
Same-named companies — This database also contains companies with near-identical names: MOZARC MEDICAL US LLC DBA COVIDIEN LLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Mansfield

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

12026 · K253469

FDA listed device types

showing 8 of 17
Accessories, Catheter 1Catheter, Peritoneal Dialysis, Single Use 1Cannula, A-V Shunt 1Catheter, Continuous Flush 1Catheter, Hemodialysis, Non-Implanted 1Catheter, Hemodialysis, Implanted, Coated 1Accessories, A-V Shunt 1Wire, Guide, Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)2026-08-06
CA8518PERMCATH CATHETERSClass III
CA107270CHAMELEON PTA BALLOON CATHETER WITH INJECTION PORTClass IV

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