HomeIsraelMizra Medical Ltd.

Mizra Medical Ltd.

Israel · Holon · www.mizramedical.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN IL-MF-000015502

This company has registrations in European Union, United States, Israel — 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
5UDI-DI device records
Class I 5
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
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.

European Union5 raw hits, 0 excluded, 5 confirmed
United States2 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: MIZRA MEDICAL LTD.

Regulatory identity

EU manufacturer SRN
IL-MF-000015502
EU authorised representative
AF Pharma Service Europe SL

Company information

Country
Israel
City
Holon
Website
www.mizramedical.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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 listed device types

Device, Incontinence, Urosheath Type, Non-Sterile 1Esthesiometer 1

Registration details (sample)

MarketIdentifierNameClass / date
EU07290018953846URONICO PACK 1 COLEC+1TIRA 35MM Male external 35mm + hystripClass I
EU07290018953839URONICO PACK 1 COLEC + 1 TIRA 30MM Male external 30mm +hystrip Class I
EU07290018953624URONICO PACK 1 COLEC + 1 TIRA 25MM Male external 30mm +hystrip Class I
EU07290018953372UROINCO PACK 30 UNITS + 30 TIRAS -35mmClass I

Similar companies

Physiclean LTD
Israel · markets 0
Neteera Inc.
Israel · markets 0
A.d.M. srl
Italy · markets 0
AAMEDIX GLOVE SDN BHD
Malaysia · markets 3
ABDOS LABTECH PRIVATE LIMITED.
India · markets 1
ACE Srl
Belgium · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →