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Intermedics, Inc.

Switzerland · Le Locle

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

211510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 211 510(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

34active device licences

Class IV 34

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 States0 registration records, 211 510(k), 0 PMA, 3 excluded

Canada34 confirmed, 1 excluded

Manufacturer names merged into this page: INTERMEDICS, SA

Registration details (sample)

Market	Identifier	Name	Class / date
US	K954610	MODEL 430-07 ENDOCARDIAL PACING LEAD	1996-12-16
US	K955122	INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD	1996-11-04
US	K962174	BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)	1996-08-21
CA	925	INTERVENE II STEROID-ELUTING IROX INTEGRATED BIPOLAR RV DEFIB.HEAD	Class IV
CA	9924	IMPLANTAID LEAD ADAPTERS	Class IV
CA	9930	INTERVENE IMPLANTABLE DEFIBRILLATION/PACING LEADDS AND ACCESSORIES	Class IV

Intermedics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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