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BIOTRONIK SE & CO. KG

Germany · Berlin

✓ Record-verifiedregistrations found in 10 markets

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

26listed device types

Class I 1Class II 11Class III 14

plus 32 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

49 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

62active device licences

Class II 10Class III 5Class IV 47

114 including historic records

TWTaiwanTFDA

32valid device licences

Class I 1Class II 8Class III 23

SGSingaporeHSA SMDR

24device registrations

CLASS B 1CLASS C 7CLASS D 12D WITH MEDICINAL PRODUCT 4

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

85active ARTG entries

Class I 7Class III 63IIa 2IIb 5Class Is (sterile) 8

HKHong KongMDACS

29valid listings

Class III 2Class IV 27

ILIsraelAMAR

26registrations

RURussiaRoszdravnadzor

31active registrations

Class 2b 6Class 3 25

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 States32 registration records, 0 510(k), 0 PMA, 10 excluded

Brazil3 confirmed, 2 excluded

Canada62 confirmed, 1 excluded

Manufacturer names merged into this page: BIOTRONIK SE & CO. KG · BIOTRONIK SE & CO KG · BIOTRONIK SE & CO KG.

FDA listed device types

showing 8 of 26

Pulse Generator, External Pacemaker, Dual Chamber 1Wire, Guide, Catheter 1Stylet, Catheter 1Analyzer, Pacemaker Generator Function 1Pulse-Generator, Pacemaker, External 1Catheter, Electrode Recording, Or Probe, Electrode Recording 1Pacemaker Lead Adaptor 1Dilator, Vessel, For Percutaneous Catheterization 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80224390177	CABO CONECTOR DO PACIENTE	Class II
BR	80224399002	Adaptador IS4/DF4	Class I
BR	80224390165	CABO DE CONEXÃO PARA CATETER DE ABLAÇÃO	Class II
CA	1960	ERA 300 PACEMAKER SYSTEM ANALYZER	Class IV
CA	1961	RETROX ACTIVE FIXATION LEADS	Class IV
CA	1962	SYNOX PASSIVE FIXATION LEADS	Class IV

BIOTRONIK SE & CO. KG

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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