HomeItalyFIAB SPA

FIAB SPA

Italy · Vicchio
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, 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
7listed device types
Class I 0Class II 7Class III 0
plus 9 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 1Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
5registered 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
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
30active ARTG entries
Class I 17IIa 4IIb 4Class Is (sterile) 5
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
20registrations
RURussiaRoszdravnadzor
5active registrations
Class 1 2Class 2a 1Class 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 States9 registration records, 7 510(k), 0 PMA
Brazil5 confirmed, 2 excluded
Saudi Arabia5 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: FIAB SPA · Fiab SpA · FIAB SpA

Company information

Country
Italy
City
Vicchio

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

22009 · K083428
12010 · K100333
12011 · K103783
12013 · K123361
12018 · K180047
12019 · K192210

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Cable, Electrode 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Dc-Defibrillator, Low-Energy, (Including Paddles) 1Unit, Cautery, Thermal, Battery-Powered 1Continuous Measurement Thermometer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK192210ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System2019-10-10
USK180047ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System2018-11-08
USK123361ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM2013-02-27
BR80443699007EURODEFIPADSClass II
BR80271290004ELETRODO PARA ECG FIABClass II
BR80271290025CABO PARA ECG FIABClass II
SAME0000001038SFDAA00009Disposable Electrodes For ECG
SAME0000001038SFDAA00010Pre Wired ECG Electrode
CA83915FULLY GELLED NEUROSTIMULATION ELECTRODESClass II
CA81029SENSITHERMClass II

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