HomePolandFREY SPOLKA JAWNA

FREY SPOLKA JAWNA

Poland · Piaseczno Mazowieckie
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Israel — 7 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
5listed device types
Class I 2Class II 3Class III 0
plus 5 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
4registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
Class I 3Class Im (measuring) 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States5 registration records, 0 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Saudi Arabia4 confirmed, 0 excluded
Manufacturer names merged into this page: FREY SPOLKA JAWNA · MEDICAL BROKERS ADAM CIESLAK SPÓLKA JAWNA · ICB Pharma Tomasz Świętosławski, Paweł Świętosławski Spółka Jawna

Company information

Country
Poland
City
Piaseczno Mazowieckie

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

Camera, Ophthalmic, General-Use 1Biomicroscope, Slit-Lamp, Ac-Powered, Exempt 1Tonometer, Ac-Powered 1Perimeter, Automatic, Ac-Powered 1Projector, Ophthalmic 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80325880001Microcânulas Vida BelaClass II
SAME0000012971SFDAA00001Nitolic® with removal comb
SAME0000014460SFDAA00008Nitolic® Applicator

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