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SOBYTEK INSTRUMENTS CO.

Pakistan · Sialkot Punjab

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

14listed device types

Class I 13Class II 1Class III 0

plus 14 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class I 5

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

0valid device licences

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

Brazil5 confirmed, 0 excluded

Manufacturer names merged into this page: SOBYTEK INSTRUMENTS CO. · Sobytek Instruments Co.

FDA listed device types

showing 8 of 14

Pusher, Band, Orthodontic 1Forceps 1Syringe, Periodontic, Endodontic, Irrigating 1Mirror, Mouth 1Tray, Impression, Preformed 1Accessories, Retractor, Dental 1Hook, Surgical, General & Plastic Surgery 1Plier, Orthodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80316910030	INSTRUMENTAIS PARA ORTODONTIA Sem Inserto	Class I
BR	80316910031	INSTRUMENTAIS PARA ORTODONTIA Não Articulado Não Cortante sem Insert	Class I
BR	80316910032	INSTRUMENTAIS PARA ORTODONTIA Com Inserto	Class I

SOBYTEK INSTRUMENTS CO.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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