AB Medical, Inc.

Korea, Republic · Jeollanam-do · www.v-tube.com

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Russia — 8 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

0UDI-DI device records

USUnited StatesFDA openFDA

42listed device types

Class I 18Class II 24Class III 0

plus 57 registration records and 47 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

19registered devices

Class I 8Class II 11

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

6registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

5active device licences

Class II 3Class III 2

11 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

11active ARTG entries

Class I 1IVD Class 1 1IIa 6IIb 1Class Im (measuring) 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 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.

European Union714,378 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States57 registration records, 47 510(k), 0 PMA, 8,871 excluded

United Kingdom0 confirmed, 1,823 excluded

Brazil19 confirmed, 2,567 excluded

Saudi Arabia6 confirmed, 967 excluded

Canada5 confirmed, 1,236 excluded

Manufacturer names merged into this page: MEDICAL GROUP · DEL MEDICAL, INC. · Z-MEDICAL GMBH & CO. KG · W-MEDICAL · MEDICAL Z · AB MEDICAL INC.

FDA 510(k) clearances by year

11979

11980

41981

31982

11983

31985

121986

51987

21988

11989

11990

11991

11993

12008

12012

12013

12014

22015

12017

12023

FDA listed device types

showing 8 of 42

Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Thoracolumbosacral Pedicle Screw System 1Screw, Fixation, Bone 1Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Collimator, Manual, Radiographic 1System, Image Processing, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223550	DMX	2023-04-10
US	K173018	MDR17 Mobile Direct Radiographic System	2017-11-20
US	K152767	OTC12D AUTO RADIOGRAPHIC SYSTEM	2015-12-14
BR	10369460103	TUBO PARA COLETA DE SANGUE A VÁCUO V-TUBE LABOR IMPORT	Class I
BR	82942910010	FAMÍLIA TUBO PARA COLETA À VACUO TERA	Class I
BR	80495510152	Medix Brasil Família de Tubo de Coleta De Sangue à Vácuo	Class I
SA	ME0000000002SFDAA00006	Medigel z	—
SA	ME0000000002SFDAA00001	MOUTH SPACER	—
CA	28423	HF-110A PORTABLE X-RAY SYSTEM	Class II
CA	28424	PH-150 PORTABLE X-RAY	Class II
CA	36529	X-RAY GENERATORS - HIGH FREQUENCY	Class III