HomeUSAKAL-MED, LLC.

KAL-MED, LLC.

USA · Kensington
✓ 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
2listed device types
Class I 1Class II 1Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 2Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
10registered 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 States2 registration records, 1 510(k), 0 PMA, 2 excluded
Brazil6 confirmed, 0 excluded
Saudi Arabia10 confirmed, 0 excluded
Manufacturer names merged into this page: KAL-MED, LLC. · STR B&#304.YO TEKNOLOJ&#304.LER&#304. MED&#304.KAL &#304.ML. &#304.TH. VE &#304.HR. SAN. T · TRANS MED&#304.KAL ALETLER SAN. VE T&#304.C. A.&#350.. · AD MED&#304.KAL VE SA&#286.LIK ÜR. SAN. &#304.C VE DI&#350. T&#304.C LTD. ST&#304.. · SCM MEDİKAL ÜRÜNLERİ TEKSTİL OTOMOTİV KUYUMCULUK İTHALAT İHRACAT SANAYİ VE TİCARET LİMİTED · FTM AMBALAJ MEDİKAL İTHALAT İHRACAT SAN.ve TİC.LTD.ŞTİ

Company information

Country
USA
City
Kensington

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

12020 · K191858

FDA listed device types

Cuff, Tracheal Tube, Inflatable 1Endoscopic Bite Block 1

Registration details (sample)

MarketIdentifierNameClass / date
USK191858Pylant Monitor2020-02-24
BR82346579004Tubo PRP CELL-X UniqueClass II
BR82346579005Tubo PRP CELL-X HighcellClass II
BR82346579006Cell-X Ultraboost CentrifugeClass II
SAME0000017420SFDAA00003scm mask
SAME0000003375SFDAA00067FTM

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