HomeUSABELMONT MEDICAL TECHNOLOGIES.

BELMONT MEDICAL TECHNOLOGIES.

USA · Billerica
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
4listed device types
Class I 0Class II 4Class III 0
plus 9 registration records and 1 510(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
2active device licences
Class II 2
10 including historic records
TWTaiwanTFDA
6valid device licences
Class II 6
SGSingaporeHSA SMDR
3device registrations
CLASS C 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
9active ARTG entries
Class I 1IIa 2IIb 6
HKHong KongMDACS
5valid listings
Class III 5
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 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.

United States9 registration records, 1 510(k), 0 PMA, 12 excluded
Brazil1 confirmed, 2 excluded
Canada2 confirmed, 2 excluded
Manufacturer names merged into this page: BELMONT MEDICAL TECHNOLOGIES · BELMONT MEDICAL TECHNOLOGIES.

Company information

Country
USA
City
Billerica

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

12024 · K242735

FDA listed device types

Warmer, Thermal, Infusion Fluid 1Warmer, Blood, Non-Electromagnetic Radiation 1Pump, Infusion 1System, Thermal Regulating 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242735Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)2024-12-23
BR10171610063Equipamento de gerenciamento de temperatura de pacienteClass II
CA63849BUDDY FLUID WARMERClass II
CA87592THE BELMONT BUDDY PLUS FLUID WARMERClass II

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