HomeAustriaCNSystems Medizintechnik GmbH

CNSystems Medizintechnik GmbH

Austria · Graz · www.cnsystems.com
✓ Record-verifiedregistrations found in 7 marketsEU SRN AT-MF-000001033

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia, Russia — 7 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
5UDI-DI device records
Class I 1Class IIa 3Class IIb 1
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 4 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 1Class IIa 2Class IIb 1
BRBrazilANVISA
3registered devices
Class I 1Class II 2
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
0active device licences
4 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 2a 1Class 2b 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.

European Union5 raw hits, 0 excluded, 5 confirmed
United States4 registration records, 3 510(k), 0 PMA
United Kingdom4 confirmed, 0 excluded
Brazil3 confirmed, 0 excluded
Manufacturer names merged into this page: CNSYSTEMS MEDIZINTECHNIK GmbH · CNSYSTEMS MEDIZINTECHNIK GMBH

Regulatory identity

EU manufacturer SRN
AT-MF-000001033
UK responsible person
International Associates Limited

Company information

Country
Austria
City
Graz
Website
www.cnsystems.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentAnaesthesia, intensive care & life-support systemsCardiology & vascular medicineNeurology & neurosurgery

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12002 · K014063
12019 · K183521
12023 · K223332

FDA listed device types

Plethysmograph, Impedance 1System, Measurement, Blood-Pressure, Non-Invasive 1

Registration details (sample)

MarketIdentifierNameClass / date
EU09120073932495Task Force CARDIOClass IIa
EU09120073933010Task Force CARDIOClass IIa
EU09120073932235CNAP Monitor 500 HDClass IIb
EU09120073931948Task Force® Monitor - Single-use electrodes setClass I
UK61020Task Force Monitor - Single-use electrodes set Class I
UK64338Task Force CORE ViewerClass IIa
UK36551AUX: Analog Out connectorClass IIb
USK223332Task Force CORE2023-04-12
USK183521CNAP Monitor2019-09-11
USK014063TASK FORCE MONITOR 30402002-02-07
BR80509090004Conjunto de eletrodos TFMClass I
BR80509099005Monitor CNAP®500Class II
BR80509099006Task Force CoreClass II

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