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PT. Nipro Indonesia Jaya

Indonesia · Karawang Jawa Barat

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel — 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

4listed device types

Class I 0Class II 4Class III 0

plus 4 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

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

2valid device licences

Class II 2

SGSingaporeHSA SMDR

9device registrations

CLASS B 9

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IIa 6

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 States4 registration records, 0 510(k), 0 PMA, 5 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: PT. Nipro Indonesia Jaya · PT NIPRO INDONESIA JAYA · PT NIPRO INDONESIA JAYA INDONESIA

Same-named companies — This database also contains companies with near-identical names: PT NIPRO INDONESIA JAYA INDONESIA. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Needle, Hypodermic, Single Lumen 1Syringe, Piston 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10324860011	LINHA DE SANGUE NIPRO	Class II
BR	80788620058	SERINGA DE INSULINA	Class II
BR	80788620056	SERINGA SEM AGULHA	Class I

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PT. Nipro Indonesia Jaya

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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