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INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S.

France · Sophia Antipolis

✓ 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

14listed device types

Class I 4Class II 5Class III 2unclassified 3

plus 50 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

30active device licences

Class II 10Class III 5Class IV 15

72 including historic records

TWTaiwanTFDA

0valid device licences

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 States50 registration records, 16 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada30 confirmed, 3 excluded

Manufacturer names merged into this page: INTEGRA NEUROSCIENCES · INTEGRA LIFESCIENCES CORPORATION DBA INTEGRA NEUROSCIENCES · INTEGRA LIFESCIENCES CORPORATION ALSO DBA INTEGRA NEUROSCIENCES · INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S. · INTEGRA NEUROSCIENCES LIMITED ALSO T/A SPEMBLY MEDICAL · INTEGRA NEUROSCIENCES PR, INC.

Same-named companies — This database also contains companies with near-identical names: INTEGRA LIFESCIENCES CORPORATION ALSO DBA INTEGRA NEUROSCIENCES, INTEGRA LIFESCIENCES CORPORATION DBA INTEGRA NEUROSCIENCES, Integra Neurosciences, Ltd., Integra Neurosciences Implants S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11999

12000

42002

32003

42004

12005

22008

FDA listed device types

showing 8 of 14

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Dura Substitute 1Shunt, Central Nervous System And Components 1Bone Grafting Material, Synthetic 1Cuff, Nerve 1Instrument, Ultrasonic Surgical 1Neurosurgical Ultrasonic Instruments 1Securement Wound Dressing For Reduction Of Infection 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K081773	OSV II	2008-11-06
US	K082250	AURAGEN CORTICAL SURFACE ELECTRODES	2008-10-10
US	K050720	NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100	2005-05-11
BR	10355870179	CONJUNTO PARA DRENAGEM EXTERNA DO LCE	Class II
CA	82470	CAMINO PRESSURE MONITORING AND DRAINAGE KITS	Class IV
CA	3661	VENTRICULAR CATHETER INTRODUCER	Class III
CA	3663	SUBCUTANEOUS PERITONEAL CATHETER PASSER	Class II

INTEGRA NEUROSCIENCES IMPLANTS (FRANCE) S.A.S.

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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