HomeIsraelMEDISPEC, LTD.

MEDISPEC, LTD.

Israel · Yehud
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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
7listed device types
Class I 3Class II 3Class III 1
plus 10 registration records and 4 510(k), 7 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
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
4active device licences
Class II 1Class III 3
9 including historic records
TWTaiwanTFDA
9valid device licences
Class II 3Class III 6
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
9active ARTG entries
IIb 9
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 2Class 2b 3
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, 4 510(k), 7 PMA
Brazil4 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: MEDISPEC, LTD. · MEDISPEC LTD. · MEDISPEC LTD

Company information

Country
Israel
City
Yehud

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.

Business registration

Legal name
MEDISPEC LTD.
Company number
511651770
Registration status
Active
Incorporated
1992-01-26

Business registration data from Israel Companies Registrar, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11998 · K974796
12004 · K040461
12007 · K063504
12023 · K210166

FDA listed device types

Generator, Shock-Wave, For Pain Relief 1Massager, Therapeutic, Electric 1Device, Digital Image Storage, Radiological 1Table, Operating-Room, Ac-Powered 1Lithotriptor, Electro-Hydraulic 1Lithotriptor, Extracorporeal Shock-Wave, Urological 1Uroflowmeter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK210166Omnispec ED10002023-01-27
USK063504ECONOLITH EM10002007-03-09
USK040461ECONOLITH E3000, MODEL 3000 (SW-6)2004-05-25
BR81544679001OMNISPEC™Class II
BR80142340035ED1000 - OMNISPECClass II
BR80142340038SLIMSPECClass II
CA67798ORTHOSPEC ESWT EXTRACORPOREAL SHOCK WAVE THERAPYClass II
CA68872ECONOLITH MODEL 2000 (E2000) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTERClass III
CA69438ECONOLITH E3000Class III

Similar companies

ACS Med Ltd.
Israel · markets 0
Biobeat Ltd.
Israel · markets 0
Bioxtreme Ltd.
Israel · markets 3
Butterfly Medical Ltd.
Israel · markets 2
Clear-Cut Medical Ltd.
Israel · markets 1
Diel Adhesives Ltd
Israel · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →