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Goldstar Medical Instruments (Partnership)

Pakistan · Sialkot · www.goldstarmed.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN PK-MF-000038114

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Australia — 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

1UDI-DI device records

Class I 1

USUnited StatesFDA openFDA

19listed device types

Class I 15Class II 4Class III 0

plus 17 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 10

BRBrazilANVISA

8registered devices

Class I 7Class II 1

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

SASaudi ArabiaSFDA

10registered 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

1active ARTG entries

Class I 1

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.

European Union1 raw hits, 0 excluded, 1 confirmed

United States17 registration records, 0 510(k), 0 PMA

United Kingdom10 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Saudi Arabia10 confirmed, 0 excluded

Manufacturer names merged into this page: GOLDSTAR MEDICAL INSTRUMENTS · Goldstar Medical Instruments · |Goldstar medical instruments

Regulatory identity

EU manufacturer SRN: PK-MF-000038114
EU authorised representative: Obelis s.a.
UK responsible person: Obelis UK Ltd

FDA listed device types

showing 8 of 19

Hook, Tracheal 1Forceps 1Gauze / Sponge,Nonresorbable For External Use 1Laryngoscope, Rigid 1Syringe, Periodontic, Endodontic, Irrigating 1Forceps, General & Plastic Surgery 1Gown, Examination 1Scissors, Orthopedic, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08964001117452	TruHold Tube Holder	Class I
UK	35815	Truhold tube holder	Class I
UK	46827	Reusable Laryngoscope Blade	Class I
UK	46828	Disposable Laryngoscope Blade	Class I
BR	81451140001	Lâmina de Laringoscópio PRMed	Class I
BR	81451140002	Cabo para Laringoscópio PRMed	Class I
BR	81451140003	Laringoscópio PRMED	Class I
SA	ME0000000265SFDAA00035	Goldstar	—
SA	ME0000013941SFDAA00008	Goldstar Miller FO Blade and Handle	—

Goldstar Medical Instruments (Partnership)

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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