HomeMercator Medical S.A.

Mercator Medical S.A.

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 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
4listed device types
Class I 4Class II 0Class III 0
plus 6 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
6registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States6 registration records, 7 510(k), 0 PMA, 3 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia6 confirmed, 0 excluded
Manufacturer names merged into this page: MERCATOR MEDICAL (THAILAND) LTD. · MERCATOR MEDICAL (THAILAND) LTD · Mercator Medical S.A. · Mercator Medical Thailand LTD · Mercator Medical (Thailand) Ltd.
Same-named companies — This database also contains companies with near-identical names: Mercator Medical (Thailand), Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

12015 · K141042
12018 · K172930
22019 · K192444
12020 · K200967
12022 · K213548
12025 · K251141

FDA listed device types

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Fentanyl And Other Opioid Protection Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251141Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate2025-11-17
USK213548Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy2022-02-21
USK200967mCare(R) Powder Free Nitrile Orange Examination Gloves2020-06-06
BR81995160018LUVA NITRILICA SEM PO-MERCATOR MEDICALClass I
SAME0000005482SFDAA00006Mercator Ambulance Examination and Protective gloves
SAME0000007896SFDAA00001mCare Powder Free Nitrile Long cuff Examination Gloves

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