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Intact Medical Corporation

USA · Framingham

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 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

2active device licences

Class III 2

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States0 registration records, 4 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: INTACT MEDICAL CORPORATION

Registration details (sample)

Market	Identifier	Name	Class / date
US	K152596	Intact® Gen2 System	2016-02-15
US	K142477	Intact Advance and Intact Excision XL, Intact BLES	2014-12-15
US	K081057	INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL	2008-06-17
CA	37022	EN-BLOC BIOPSY SYSTEM	Class III
CA	60236	NEOTHERMIA SITE MARKER	Class III

Intact Medical Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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