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MED-LOGICS, INC.

USA · Athens

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 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

8listed device types

Class I 6Class II 2Class III 0

plus 15 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 6Class 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

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

4valid device licences

Class I 3Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States15 registration records, 12 510(k), 0 PMA, 4 excluded

Brazil10 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: MED-LOGICS, INC. · MED-LOGICS, Inc.

FDA 510(k) clearances by year

11996

21997

21998

12000

32001

22002

12004

FDA listed device types

Burr, Corneal, Manual 1Device, Irrigation, Ocular Surgery 1Marker, Ocular 1Cystotome 1Keratome, Ac-Powered 1Specula, Ophthalmic 1Unit, Phacofragmentation 1Sponge, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K033293	MED-LOGICS, MODEL ML7090	2004-01-13
US	K022982	MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB	2002-11-15
US	K022716	MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB	2002-10-11
BR	82236550001	Microesponja CleanTouch	Class I
BR	82236559001	Lâminas CLB	Class II
BR	82236550002	Tubos Estéreis	Class I
CA	30121	ML BLADE	Class II

MED-LOGICS, INC.

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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