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Home›Poland›Radiometer Solutions Sp. z o.o.

Radiometer Solutions Sp. z o.o.

Poland · Stargard Zachodniopomorskie
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 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
26listed device types
Class I 5Class II 21Class III 0
plus 37 registration records and 0 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 1IVD 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 States37 registration records, 0 510(k), 0 PMA, 10 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Radiometer Sp. z o.o · Radiometer Solutions Sp. z o.o.
Same-named companies — This database also contains companies with near-identical names: Radiometer Sp. z o.o. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Poland
City
Stargard Zachodniopomorskie

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 listed device types

showing 8 of 26
System, Hemoglobin, Automated 1Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia 1Oximeter, Ear 1Electrode, Ion-Specific, Chloride 1Syringe, Antistick 1Oximeter 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1Assay, Fetal Hemoglobin 1

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