Home›Taiwan›MICROWARE PRECISION CO., LTD.

MICROWARE PRECISION CO., LTD.

Taiwan · Taichung

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

24listed device types

Class I 7Class II 17Class III 0

plus 34 registration records and 8 510(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

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 States34 registration records, 8 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: MICROWARE PRECISION CO., LTD.

FDA 510(k) clearances by year

12008

12012

12018

12019

22022

12023

12024

FDA listed device types

showing 8 of 24

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis 1Plate, Bone 1Screw, Fixation, Intraosseous 1Thoracolumbosacral Pedicle Screw System 1Orthosis, Spinal Pedicle Fixation 1Orthosis, Spondylolisthesis Spinal Fixation 1Plate, Fixation, Bone 1

Market	Identifier	Name	Class / date
US	K242814	Tandry Q-Locking Plate System	2024-11-14
US	K230690	Tandry Locking Plate System	2023-08-17
US	K220360	Tandry CMF Plate System	2022-11-10

MICROWARE PRECISION CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies