HomeSwitzerlandDisetronic Medical Systems AG

Disetronic Medical Systems AG

Switzerland · St. Paul
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
29510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 29 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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, 29 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: DISETRONIC MEDICAL SYSTEMS AG

Company information

Country
Switzerland
City
St. Paul

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

11991
21992
11993
11995
11996
31997
21998
51999
12000
22001
32002
22004
12005
22006
12007
12010

Registration details (sample)

MarketIdentifierNameClass / date
USK100704ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE2010-05-14
USK070189ACCU-CHEK ULTRAFLEX INFUSION SET2007-02-21
USK063146ACCU-CHEK LINKASSIST2006-11-27
BR80347309001NutropinAq® PenClass II

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