HomeIsraelOneg HaKarmel ltd

Oneg HaKarmel ltd

Israel · Tirat Carmel · www.hemashock.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN IL-MF-000028966

This company has registrations in European Union, United States, Brazil, Taiwan, Australia, Russia — 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
15UDI-DI device records
Class I 15
USUnited StatesFDA openFDA
1listed device types
Class I 1Class II 0Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
6registered devices
Class I 6
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
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 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.

European Union15 raw hits, 0 excluded, 15 confirmed
United States1 registration records, 0 510(k), 0 PMA
Brazil6 confirmed, 0 excluded
Manufacturer names merged into this page: Oneg HaKarmel LTD · ONEG HAKARMEL LTD. (OHK MEDICAL DEVICES) · ONEG HAKARMEL LTD (OHK - MEDICAL DEVICES).

Regulatory identity

EU manufacturer SRN
IL-MF-000028966
EU authorised representative
MedNet EC-REP GmbH

Company information

Country
Israel
City
Tirat Carmel
Website
www.hemashock.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentEmergency, Rescue & Disaster Medicine

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

Company number
512810474
Registration status
Active
Incorporated
1999-07-27

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

FDA listed device types

Tourniquet, Nonpneumatic 1

Registration details (sample)

MarketIdentifierNameClass / date
EU07290012685224HemaClear GreenClass I
EU07290012685460HemaClear XL (double sleeve)Class I
EU07290012685484HemaClear Long PinkClass I
EU07290012685415HemaClear XXLClass I
BR82058970001HemaClearClass I
BR10448330064Torniquete HemaclearClass I
BR80006170008TORNIQUETE ARTERIAL DE MEMBRO S-MARTClass I

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