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BEN S.R.L. BIOCHEMICAL ENTERPRISE

✓ Record-verifiedregistrations found in 2 marketsEU SRN IT-MF-000021057

This company has registrations in European Union, Brazil — 2 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

14UDI-DI device records

IVD A 7IVD general 7

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

30registered devices

Class I 2Class II 28

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

pendingnot queried

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 Union248 raw hits, 234 excluded, 14 confirmed

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

United Kingdom0 confirmed, 1 excluded

Brazil30 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BEN BIOCHEMICAL ENTERPRISE SRL · BEN S.R.L. BIOCHEMICAL ENTERPRISE · BEN S.R.L - BIOCHEMICAL ENTERPRISE · BEN SRL BIOCHEMICAL ENTERPRISE

Regulatory identity

EU manufacturer SRN: IT-MF-000021057

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08033622176152	OXALATE URINE PURIFIER	IVD A
EU	08033622176091	G6PDH-RED CELL LYSING REAGENT (only for automation)	IVD A
EU	08033622178125	Coag Kaolin	IVD A
EU	08033622178118	Coag Cleaning Solution	IVD A
BR	80464810514	FAMÍLIA ACE	Class II
BR	80464810515	FAMÍLIA OXALATO	Class II
BR	80464810544	FAMÍLIA ÁCIDO CÍTRICO	Class II

BEN S.R.L. BIOCHEMICAL ENTERPRISE

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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