HomeSwitzerlandCascination AG

Cascination AG

Switzerland · Bern
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel — 6 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
3listed device types
Class I 0Class II 3Class III 0
plus 6 registration records and 6 510(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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 2IIa 1IIb 1Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 States6 registration records, 6 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: CASCINATION · CASCINATION AG

Company information

Country
Switzerland
City
Bern

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

12015 · K143024
12016 · K152473
12021 · K203486
12022 · K220300
12024 · K232022
12025 · K242120

FDA listed device types

Tracking, Soft Tissue, Intraoperative 1Image Management Software For Planning Of Otologic And Neurotologic Procedures 1System, X-Ray, Tomography, Computed 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242120OTOPLAN2025-04-11
USK232022CAS-One IR2024-03-13
USK220300OTOPLAN2022-06-24
BR81692270016OTOPLANClass II

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