HomeSwitzerlandAcutronic Medical Systems AG

Acutronic Medical Systems AG

Switzerland · Hirzel
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, 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
pendingnot queried
USUnited StatesFDA openFDA
12510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
3 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 2IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 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 States0 registration records, 12 510(k), 0 PMA
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: ACUTRONIC MEDICAL SYSTEMS AG

Company information

Country
Switzerland
City
Hirzel

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

41986
21987 · K863155
11989 · K883865
21991 · K900745
11995 · K936009
22002 · K012691

Registration details (sample)

MarketIdentifierNameClass / date
USK012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES2002-12-20
USK012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES2002-08-01
USK936009AMS 3000M1995-05-03
CA98854INFANTVIEWClass II

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