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Integra LifeSciences Switzerland Sarl

Switzerland · Le Locle

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 10 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

6listed device types

Class I 2Class II 4Class III 0

plus 46 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

12 including historic records

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

13 including historic records

TWTaiwanTFDA

4valid device licences

Class II 4

SGSingaporeHSA SMDR

4device registrations

CLASS C 1CLASS D 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

14active ARTG entries

Class I 7Class III 6IIa 1

HKHong KongMDACS

3valid listings

Class II 2Class IV 1

ILIsraelAMAR

5registrations

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 States46 registration records, 0 510(k), 0 PMA, 22 excluded

Brazil0 confirmed, 7 excluded

Saudi Arabia2 confirmed, 1 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: Integra LifeSciences Switzerland Sarl · INTEGRA LIFESCIENCES SWITZERLAND SARL

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Catheter, Ventricular 1Shunt, Central Nervous System And Components 1Device, Monitoring, Intracranial Pressure 1Instrument, Surgical, Non-Powered 1Tray, Surgical, Instrument 1

Market	Identifier	Name	Class / date
SA	ME0000015848SFDAA00005	CODMAN® CERTAS™ Tool Kit	—
SA	ME0000015848SFDAA00006	CODMAN CERTAS® X-Ray Overlay Tool	—

Integra LifeSciences Switzerland Sarl

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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