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PT. MEDISAFE TECHNOLOGIES

Indonesia · Medan

✓ Record-verifiedregistrations found in 6 markets

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

6listed device types

Class I 6Class II 0Class III 0

plus 42 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

7active ARTG entries

Class I 3IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 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 States42 registration records, 19 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 1 excluded

Saudi Arabia1 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: PT. MEDISAFE TECHNOLOGIES · PT MEDISAFE TECHNOLOGIES

FDA 510(k) clearances by year

22001

12003

32004

22005

12008

12010

12011

12012

12014

22015

12017

12018

12019

12020

FDA listed device types

Surgeon'S Gloves 1Fentanyl And Other Opioid Protection Glove 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Medical Glove, Specialty 1Latex Patient Examination Glove 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201774	Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs	2020-09-16
US	K182176	Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs	2019-03-28
US	K173258	Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy	2018-04-20
BR	81981090013	LUVA NEOVOLK CIRÚRGICA	Class II
BR	81981090014	LUVA PARA PROCEDIMENTO CIRÚRGICO NEOVOLK CIRÚRGICA	Class II
BR	82732939001	LUVA PARA PROCEDIMENTO CIRÚRGICO NEO CIRÚRGICA	Class II
SA	ME0000005588SFDAA00001	BLOSSOM	—

PT. MEDISAFE TECHNOLOGIES

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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