HomeIsraelElcam Medical Acal LTD.

Elcam Medical Acal LTD.

Israel · Dalton Industrial Park P.O Box Northern
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, South Korea, Australia, Israel — 5 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
6listed device types
Class I 0Class II 6Class III 0
plus 14 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States14 registration records, 16 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: ELCAM MEDICAL ACAL · Elcam Medical Acal LTD.

Company information

Country
Israel
City
Dalton Industrial Park P.O Box Northern

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

12003
12004
32006
12008
12010
12011
32012
12013
12014
12019
12022
12023

FDA listed device types

Stopcock, I.V. Set 1Syringe, Piston 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Set, Administration, Intravascular 1Catheter, Intravascular, Diagnostic 1Transducer, Blood-Pressure, Extravascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231900A-TAP (previously called Arthrotap)2023-07-25
USK211204SafePort(TM) Manifold (or Stopcock)2022-09-15
USK190489Elcam Stopcocks and Manifolds2019-04-23
BR80136990766Dispositivo de transferência para mistura e administraçãoClass II
BR80415440014TORNEIRA VALVULADAClass II

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