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Formatk Systems , Ltd.

Israel · Tirat Hacarmel

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel, 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

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 4 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

2 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 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.

United States4 registration records, 4 510(k), 0 PMA

Manufacturer names merged into this page: FORMATK SYSTEMS LTD.

FDA 510(k) clearances by year

32016 · K162781

12018 · K183307

FDA listed device types

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Massager, Vacuum, Radio Frequency Induced Heat 1Powered Laser Surgical Instrument 1Lamp, Infrared, Therapeutic Heating 1Brush, Dermabrasion, Powered 1

Market	Identifier	Name	Class / date
US	K183307	Magma Spark Pro (Magma Spark Plus, Alpha)	2018-12-11
US	K162781	Magma Spark	2016-11-09
US	K160195	Forma System, Forma Light System	2016-04-15

Formatk Systems , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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