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JR Engineering and Medical Technologies (M) Sdn. Bhd.

Malaysia · Rasa Selangor

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Israel — 3 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 10 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

2registered 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

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States10 registration records, 10 510(k), 0 PMA, 13 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: JR ENGINEERING AND MEDICAL TECHNOLOGIES (M) SDN BHD · JR Engineering and Medical Technologies (M) Sdn. Bhd. · JR Engineering and Medical rechnologies (M) Sdn. Bhd.

FDA 510(k) clearances by year

12019

22020 · K192328

12021 · K212827

52022 · K221626

12023 · K222350

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	K222350	Sterile Nitrile Surgical Gloves Powder Free	2023-04-13
US	K221626	Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate	2022-12-07
US	K222348	JR MEDIC	2022-10-27
SA	ME0000000884SFDAA00004	JR Medic - Skin Shield	—
SA	ME0000001331SFDAA00003	JR MEDIC SKIN SHIELD	—

JR Engineering and Medical Technologies (M) Sdn. Bhd.

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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