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Syntec Scientific Corporation

Taiwan · Chang Hua Changhua

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

44listed device types

Class I 18Class II 26Class III 0

plus 55 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

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.

United States55 registration records, 20 510(k), 0 PMA, 2 excluded

Manufacturer names merged into this page: SYNTEC SCIENTIFIC CORP.

FDA 510(k) clearances by year

41998

41999

22009

12010

12011

12012

12015

12017

22019

22020

12021

FDA listed device types

showing 8 of 44

Instrument, Bending Or Contouring 1Screwdriver 1Forceps 1Reamer 1Wrench 1Bit, Surgical 1Cannula, Surgical, General & Plastic Surgery 1Driver, Prosthesis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K202790	Syntec Orthodontic Mini Screw Extended System	2021-09-17
US	K202935	Syntec Femoral Nail Extended System	2020-10-28
US	K200933	Syntec Non-Sterile Steinmann Pins System	2020-05-05

Syntec Scientific Corporation

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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