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Intai Technology Corporation

Taiwan · Taichung City

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 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

29listed device types

Class I 8Class II 21Class III 0

plus 67 registration records and 5 510(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

5device registrations

CLASS C 5

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 States67 registration records, 5 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT · INTAI TECHNOLOGY CORP.

Same-named companies — This database also contains companies with near-identical names: INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12006 · K063020

12013 · K122804

12019 · K180523

22022 · K210422

FDA listed device types

showing 8 of 29

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component 1Posterior Cervical Screw System 1Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Catheter, Intracardiac Mapping, High-Density Array 1Screw, Fixation, Bone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210422	INTAI Surgical Mask (non-sterile)	2022-03-30
US	K201229	Intai Anatomic Locking Plate and Screw System	2022-03-11
US	K180523	INTAI Surgery Navigation System	2019-09-20

Intai Technology 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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