Home›Italy›I-Tech Industries, Inc.

I-Tech Industries, Inc.

Italy · Bologna Bologna

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 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

19listed device types

Class I 6Class II 12Class III 0unclassified 1

plus 53 registration records and 4 510(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

1registrations

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 States53 registration records, 4 510(k), 0 PMA, 472 excluded

Brazil0 confirmed, 131 excluded

Saudi Arabia0 confirmed, 35 excluded

Canada0 confirmed, 42 excluded

Manufacturer names merged into this page: Tech Industries. Inc. · PT K-TECH INDUSTRIES · I-TECH INDUSTRIES SRL

Same-named companies — This database also contains companies with near-identical names: PT K-TECH INDUSTRIES, Tech Industries. Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11987 · K874634

11988 · K875319

12019 · K182453

12021 · K211272

FDA listed device types

showing 8 of 19

Thoracolumbosacral Pedicle Screw System 1Appliance, Fixation, Spinal Intervertebral Body 1Orthosis, Spondylolisthesis Spinal Fixation 1Appliance, Fixation, Spinal Interlaminal 1Intervertebral Fusion Device With Bone Graft, Lumbar 1Intervertebral Fusion Device With Bone Graft, Cervical 1Plate, Fixation, Bone 1Spinal Vertebral Body Replacement Device 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K211272	ICOONE Laser Med (also referred to as ICOONE Medical laser)	2021-06-22
US	K182453	ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)	2019-01-11
US	K875319	NSN #6515-00-690-3209 DEBAKEY TISSUE FORCEPS	1988-01-22

I-Tech Industries, Inc.

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