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Home›Costa Rica›Creganna Medical S. R. L

Creganna Medical S. R. L

Costa Rica · San Rafael Heredia
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, South Korea — 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
7listed device types
Class I 0Class II 7Class III 0
plus 7 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States7 registration records, 6 510(k), 0 PMA
Manufacturer names merged into this page: CREGANNA MEDICAL IRELAND LIMITED · TacPro, LLC dba Creganna Medical · Creganna Medical S. R. L · CREGANNA MEDICAL · CREGANNA MEDICAL ALSO DOING BUSINESS AS CREGANNA TACTX MEDICAL
Same-named companies — This database also contains companies with near-identical names: CREGANNA MEDICAL. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Costa Rica
City
San Rafael Heredia

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

12011 · K110133
12013 · K131079
12014 · K140338
12016 · K152913
12017 · K162253
12018 · K171819

FDA listed device types

Catheter, Continuous Flush 1Catheter, Percutaneous, Neurovasculature 1Esophageal Dilator Balloon With Or Without Electrode Sensors 1Catheter, Intravascular, Diagnostic 1Catheter, Intravascular Occluding, Temporary 1Catheter, Percutaneous 1Introducer, Catheter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171819Attain Assist CS Access Catheter2018-01-04
USK162253Trapper Exchange Device2017-01-06
USK152913GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle2016-07-21

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