Home›Germany›Livanova Deutschland, GmbH

Livanova Deutschland, GmbH

Germany · Munich

✓ 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

11listed device types

Class I 1Class II 9Class III 0unclassified 1

plus 30 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class III 4

21 including historic records

TWTaiwanTFDA

10valid device licences

Class I 1Class II 9

SGSingaporeHSA SMDR

4device registrations

CLASS C 4

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

11active ARTG entries

Class I 2IIa 2IIb 6Class Im (measuring) 1

HKHong KongMDACS

4valid listings

Class III 4

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 2Class 3 2

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 States30 registration records, 7 510(k), 0 PMA, 3 excluded

Brazil0 confirmed, 2 excluded

Canada4 confirmed, 2 excluded

Manufacturer names merged into this page: LivaNova Deutschland GmbH · LIVANOVA DEUTSCHLAND GMBH

FDA 510(k) clearances by year

12020 · K191402

32021 · K212003

12022 · K220635

22023 · K232291

FDA listed device types

showing 8 of 11

Display, Cathode-Ray Tube, Medical 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 1Control, Pump Speed, Cardiopulmonary Bypass 1Console, Heart-Lung Machine, Cardiopulmonary Bypass 1Apparatus, Autotransfusion 1Controller, Temperature, Cardiopulmonary Bypass 1Gas Control Unit, Cardiopulmonary Bypass 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232291	Essenz HLM, Essenz ILBM	2023-08-24
US	K221373	Essenz HLM	2023-03-09
US	K220635	Heater-Cooler System 3T	2022-11-16
CA	6989	SIII HEART LUNG MACHINE MODULAR SYSTEM	Class III
CA	60433	STOCKERT COMPACT SYSTEM	Class III
CA	93837	FLEXTHERM HEATER-COOLER SYSTEM	Class III