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Integra Burlington Ma, Inc.

USA · Burlington

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

19active device licences

Class II 14Class III 3Class IV 2

33 including historic records

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 States0 registration records, 2 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Canada19 confirmed, 0 excluded

Manufacturer names merged into this page: INTEGRA BURLINGTON MA, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K113570	INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP	2012-02-22
US	K111741	INTEGRA(TM) CUSA NXT(TM) BONE TIPS	2011-08-23
BR	10099430198	SISTEMA ESTEREOTÁXICO CRW PRECISION	Class II
CA	3598	XPLAN 2.0	Class II
CA	9272	SSE SIEGFRIED STEREO ELECTRODE KIT	Class II
CA	10354	ICP. TELE-MONITOR SYSTEM IMPLANT	Class IV

Integra Burlington Ma, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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