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Medline International B.V.

Malaysia · Gelang Patah Johor

✓ Record-verifiedregistrations found in 3 markets

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

11listed device types

Class I 5Class II 6Class III 0

plus 14 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

25active ARTG entries

Class I 12Class Is (sterile) 13

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 States14 registration records, 0 510(k), 0 PMA, 33 excluded

Brazil2 confirmed, 14 excluded

Saudi Arabia0 confirmed, 4 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: Medline International B.V. · YANGHZOU MEDLINE INTERNATIONAL COM., LTD

FDA listed device types

showing 8 of 11

Ventilator, Non-Continuous (Respirator) 1Wire, Guide, Catheter 1Nebulizer (Direct Patient Interface) 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Catheter, Intravascular, Diagnostic 1Mask, Oxygen, Non-Rebreathing 1Set, Tubing And Support, Ventilator (W Harness) 1

Market	Identifier	Name	Class / date
BR	80614390017	BOLSA ESTÉRIL PARA DRENAGEM DE URINA	Class I
BR	80037529007	TORNEIRA DE 3 VIAS EXELLENT	Class II

Medline International B.V.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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