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BIONEN SRL

Italy · Firenze (FI) · www.bionen.it

✓ Record-verifiedregistrations found in 4 marketsEU SRN IT-MF-000018461

This company has registrations in European Union, United States, United Kingdom, Australia — 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 243Class IIa 57

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

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union430 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States2 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom1 confirmed, 0 excluded

Manufacturer names merged into this page: BIONEN SRL

Regulatory identity

EU manufacturer SRN: IT-MF-000018461
UK responsible person: Comply Express Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08033315122084	Cavo adattatore per cuffie precablate	Class I
EU	08033315121971	Cavo adattatore per cuffie precablate	Class I
EU	08033315127669	Cavo adattatore per cuffie precablate	Class I
EU	08033315121933	Elettrodo ad ago subdermale (monouso)	Class IIa
UK	35562	FASTIP	Class IIa

BIONEN SRL

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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