HomePolandEMED SP. Z O.O. SP. K.

EMED SP. Z O.O. SP. K.

Poland · Opacz Kolonia · www.emed.pl
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 6 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
0UDI-DI device records
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
17registered device records
Class I 5Class IIb 12
BRBrazilANVISA
0registered devices
3 including historic records
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
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.

European Union11,445 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified
United States0 registration records, 0 510(k), 0 PMA, 3 excluded
United Kingdom17 confirmed, 40 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: EMED SP. Z O.O. SP. K. · EMED SP. Z.O.O.SP.K · EMED SP. Z O. O. SP. K.

Regulatory identity

UK responsible person
MDQ Services Ltd

Company information

Country
Poland
City
Opacz Kolonia
Website
www.emed.pl
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

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.

Registration details (sample)

MarketIdentifierNameClass / date
UK40596SpectrumLine trolley with argon cylinder case for electrosurgical unitsClass I
UK40596SpectrumLine trolley with argon cylinder case for electrosurgical unitsClass I
UK35041Disposable neutral electrode cable, L: 3m, flat plugClass I
SAME0000001942SFDAA00012Smoke Evacuation Aria

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