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Home›Israel›MEGO AFEK MEDICAL DIVISION

MEGO AFEK MEDICAL DIVISION

Israel
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 19 registration records and 23 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 1Class 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
5active device licences
Class II 5
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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 States19 registration records, 23 510(k), 0 PMA
Brazil5 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: MEGO AFEK AC Ltd. · MEGO AFEK AC LTD. · MEGO AFEK MEDICAL DIVISION · Mego Afek AC Ltd
Same-named companies — This database also contains companies with near-identical names: Mego Afek , Ltd., Mego Afek AC , Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Israel

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

11981
12001
12006
12007
12008
22010
12011
12012
12013
32014
12015
32017
32019
12022
12023
12026

FDA listed device types

Sleeve, Limb, Compressible 1Massager, Powered Inflatable Tube 1Vibrator, Therapeutic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK254267NanoPress 760A-BT (760A-BT)2026-02-24
USK230385Ballancer Platinum (1222)2023-04-04
USK214053Amputee Garment for use with Lympha Press Optimal Plus2022-04-14
BR80153030164sistema de terapia de compressão sequencialClass II
BR80153030162SISTEMA DE COMPRESSÃO PNEUMÁTICAClass II
BR80153030004BALLANCERClass II
CA60739LYMPHA PRESS COMPRESSORSClass II
CA77764PETITE BASIC SYSTEM MODEL 701AClass II
CA80142LYMPHA PRESS AIR HOSE BUNDLEClass II

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