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Biotronik GmbH & Co. KG

USA · Bulach

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 9 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

32listed device types

Class I 0Class II 14Class III 17unclassified 1

plus 39 registration records and 104 510(k), 1,084 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

21 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class IV 3

18 including historic records

TWTaiwanTFDA

20valid device licences

Class II 13Class III 7

SGSingaporeHSA SMDR

17device registrations

CLASS B 3CLASS C 3CLASS D 5D WITH MEDICINAL PRODUCT 6

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 2Class III 6IIa 4IIb 2

HKHong KongMDACS

18valid listings

Class II 3Class III 2Class IV 13

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States39 registration records, 104 510(k), 1,084 PMA, 6 excluded

Brazil6 confirmed, 4 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: BIOTRONIK, INC. · BIOTRONIK AG

FDA 510(k) clearances by year

32006

32007

42008

22009

22010

42011

32013

22014

42015

22016

32017

12018

32019

32020

12021

32022

22023

32024

12025

12026

FDA listed device types

showing 8 of 32

Coronary Drug-Eluting Stent 1Defibrillator, Implantable, Dual-Chamber 1Stent, Superficial Femoral Artery 1Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode 1Permanent Pacemaker Electrode 1Stent, Iliac 1Stent, Coronary 1Pacemaker/Icd/Crt Non-Implanted Components 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261074	BIOMONITOR IV (471155)	2026-05-01
US	K250706	Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	2025-04-04
US	K242969	Pantera Pro; Pantera LEO	2024-10-25
BR	80224390292	Cateter Balão para Dilatação Periférica Passeo-35 Xeo	Class II
BR	80312279057	Catéter Balão pra Dilatação Periférica - PASSEO-14	Class II
BR	80312279058	Catéter Balão pra Angioplastia Periférica - PASSEO-35 XEO	Class II
CA	71868	ELECT CORONARY BALLOON CATHETER	Class IV
CA	89598	PRO-KINETIC ENERGY COBALT CHROMIUM (COCR) CORONARY STENT SYSTEM	Class IV
CA	100434	PULSAR-18 PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM	Class IV

Biotronik GmbH & Co. KG

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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