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A Plus Medical

USA · Carlsbad

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia — 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

31listed device types

Class I 12Class II 17Class III 0unclassified 2

plus 54 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

36registered devices

Class I 21Class II 15

37 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 5IIa 3IIb 1Class Is (sterile) 5

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 States54 registration records, 19 510(k), 0 PMA, 56 excluded

Brazil36 confirmed, 7 excluded

Saudi Arabia3 confirmed, 4 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: FOSHAN NANHAI PLUS MEDICAL CO LTD · BQ PLUS MEDICAL CO.,LTD · JIANGXI VISION PLUS MEDICAL TECHNOLOGY CO.,LTD · BQ PLUS MEDICAL CO., LTD. · FOSHAN NANHAI PLUS MEDICAL CO.,LTD · BQ PLUS MEDICAL CO., LTD

FDA 510(k) clearances by year

12003

22009

22010

22011

12012

22015

22021

52022

12023

12024

FDA listed device types

showing 8 of 31

Endoscope Channel Accessory 1Gown, Surgical 1Endoscopic Injection Needle, Gastroenterology-Urology 1Wrap, Sterilization 1Arthroscope 1Gown, Isolation, Surgical 1Drape, Surgical, Exempt 1Syringe, Piston 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242126	I.V. Administration Set	2024-08-22
US	K223645	I.V. Administration Set, I.V. Extension Set	2023-05-18
US	K222480	Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)	2022-11-14
BR	80201960246	JALECO/AVENTAL/CAPOTE REFORÇADO DESCARTÁVEL ESTÉRIL PLUS WINNER	Class I
BR	80201960247	COBERTURA DE EQUIPAMENTO ESTÉRIL PLUS WINNER	Class I
BR	80201960257	KIT BÁSICO II DE CAMPOS CIRÚRGICOS ESTÉRIL PLUS WINNER	Class I
SA	ME0000002172SFDAA00020	Electric Wheelchair	—
SA	ME0000002172SFDAA00020	Electric Wheelchair	—

A Plus Medical

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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