HomeSwitzerlandBelimed, Inc.

Belimed, Inc.

Switzerland · Ballwil
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 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 1Class II 2Class III 0
plus 12 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
1active device licences
Class II 1
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
8device registrations
CLASS C 8
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIb 3
HKHong KongMDACS
6valid listings
Class III 6
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 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 States12 registration records, 3 510(k), 0 PMA, 2 excluded
Canada1 confirmed, 2 excluded
Manufacturer names merged into this page: BELIMED AG

Company information

Country
Switzerland
City
Ballwil

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

12013 · K130172
12017 · K170228
12019 · K191896

FDA listed device types

Sterilizer, Steam 1Disinfector, Medical Devices 1Cleaner, Ultrasonic, Medical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK191896Belimed Steam Sterilizer MST-H TOP 50002019-10-31
USK170228Belimed Steam Sterilizer MST-H TOP 50002017-05-12
USK130172BELIMED STEAM STERILIZER MST-V2013-09-23
CA82690WASHER DISINFECTORSClass II

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