HomeIsraelWaismed, Ltd.

Waismed, Ltd.

Israel · Rosh Ha'Ayin
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, 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
5listed device types
Class I 2Class II 3Class III 0
plus 10 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
4device registrations
CLASS B 4
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States10 registration records, 7 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Waismed Ltd. · WAISMED LTD. · WAISMED LTD

Company information

Country
Israel
City
Rosh Ha'Ayin

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

11998
12002
12006
12014
12016
12019
12021

FDA listed device types

Needle, Interosseous 1Needle, Hypodermic, Single Lumen 1Intravenous Extension Tubing Set 1Device, Intravascular Catheter Securement 1Tourniquet, Nonpneumatic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK211968NIO+ Adult2021-07-22
USK190538NIO-I2019-10-07
USK160805NIO-P2016-06-23
BR80469670008NIOClass II
CA68354BONE INJECTION GUN (B.I.G.)Class II

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