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Aktina Medical Corporation

USA · Congers

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Singapore, South Korea — 4 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

7listed device types

Class I 4Class II 3Class III 0

plus 17 registration records and 17 510(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

1active device licences

Class II 1

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

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 States17 registration records, 17 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: AKTINA MEDICAL CORP.

FDA 510(k) clearances by year

21997

21998

21999

12000

12001

12002

12003

12004

12008

12011

12013

12015

12016

12019

FDA listed device types

Accelerator, Linear, Medical 1Couch, Radiation Therapy, Powered 1Block, Beam-Shaping, Radiation Therapy 1Holder, Radiographic Cassette, Wall-Mounted 1Monitor, Patient Position, Light-Beam 1Film, Radiographic 1Instrument, Quality-Assurance, Radiologic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K192102	Thermoplastic Masks	2019-09-25
US	K161984	Interlocked Circular Small Field Collimators, Elekta Integrated	2016-09-27
US	K151097	Active Breathing Coordinator	2015-05-15
CA	66329	ACTIVE BREATHING COORDINATOR	Class II

Aktina Medical Corporation

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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