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FIAB S.p.A.

Italy · Vicchio (FI) · www.fiab.it

✓ Record-verifiedregistrations found in 4 marketsEU SRN IT-MF-000005988

This company has registrations in European Union, Brazil, Taiwan, Israel — 4 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 22Class IIa 3Class IIb 275

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

6registered devices

Class I 1Class II 5

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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.

European Union2,960 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 2 excluded

United Kingdom0 confirmed, 1 excluded

Brazil6 confirmed, 1 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: FIAB S.P.A. · FIAB S.P.A

Regulatory identity

EU manufacturer SRN: IT-MF-000005988

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08054751934017	—	Class I
EU	18054751933987	—	Class I
EU	18054751933970	—	Class I
EU	18054751933963	—	Class I
BR	80239100006	CABO PARA MEDIÇÃO DE LIMIARES DE ESTIMULAÇÃO CARDÍACA	Class I
BR	80239109003	Cabo do paciente ECG	Class II
BR	80239109001	ACESSÓRIO PARA BAINHA DE DILATAÇÃO	Class II

FIAB S.p.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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