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Home›Poland›GOOD MEDICA SP.ZO.O.

GOOD MEDICA SP.ZO.O.

Poland · Wroclaw Dolno?L?Skie
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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
36listed device types
Class I 22Class II 14Class III 0
plus 48 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
21registered devices
Class I 20Class II 1
31 including historic records
SASaudi ArabiaSFDA
12registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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 States48 registration records, 1 510(k), 0 PMA
Brazil21 confirmed, 1 excluded
Saudi Arabia12 confirmed, 0 excluded
Manufacturer names merged into this page: ArjoHuntleigh Polska Sp. zo.o. · Solventum Poland Manufacturing SP. ZO.O · GOOD MEDICA SP.ZO.O. · 3Shape Poland Sp. zo.o · ChM Sp. zo.o. · EM-MED SP. ZO.O. SP. K.
Same-named companies — This database also contains companies with near-identical names: Mri-Tech Sp. Zo.O.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Poland
City
Wroclaw Dolno?L?Skie

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

12009 · K090080

FDA listed device types

showing 8 of 36
Bed, Patient Rotation, Powered 1Light-Induced Fluorescence Caries Detector 1Sleeve, Limb, Compressible 1Stretcher, Wheeled 1Bath, Hydro-Massage 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Adhesive, Bracket And Tooth Conditioner, Resin 1Bracket, Ceramic, Orthodontic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK090080CIRRUS OPEN2009-03-23
BR80530180031INSTRUMENTAL PARA PARAFUSOS ÓSSEOS 4,5/6,5MM CHMClass I
BR80530180032INSTRUMENTAL PARA PARAFUSOS ÓSSEOS 2,7/3,5MM CHMClass I
BR80530180058Instrumental para Parafusos Canulados de Ø5,0/7,0mm ChMClass I
SAME0000002725SFDAA00001GAMMA—
SAME0000000276SFDAA00009Jupiter—

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