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PT. Sugih Instrumendo Abadi

Indonesia · Bandung Barat · www.abnmedical.com

✓ Record-verifiedregistrations found in 3 markets

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

0UDI-DI device records

USUnited StatesFDA openFDA

5listed device types

Class I 4Class II 1Class III 0

plus 5 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class I 1

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

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 States5 registration records, 1 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: SUGIH INSTRUMENDO ABADI, PT · PT. SUGIH INSTRUMENDO ABADI · PT SUGIH INSTRUMENDO ABADI

Registration details (sample)

Market	Identifier	Name	Class / date
US	K012444	ABN ANEROID SPHYGMOMANOMETER	2001-08-16
BR	80070210070	BRAÇADEIRA COM MANGUITO LIVRE DE LÁTEX MD	Class I
SA	ME0000007378SFDAA00001	ABN™ CLASSIC OPTIMA	—
SA	ME0000007378SFDAA00002	ABN™ CLASSIC	—

PT. Sugih Instrumendo Abadi

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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