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Alifax S.r.l.

Italy · Polverara (PD) · www.alifax.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN IT-MF-000030029

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, 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

33UDI-DI device records

IVD A 21IVD C 12

USUnited StatesFDA openFDA

2listed device types

Class I 2Class II 0Class III 0

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

9registered device records

IVD A 6IVD general 3

BRBrazilANVISA

30registered devices

Class I 19Class II 11

33 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

6active device licences

Class II 6

14 including historic records

TWTaiwanTFDA

5valid device licences

Class I 3Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 1 3IVD Class 2 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

13active registrations

Class 1 2Class 2a 6Class 2b 5

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 Union33 raw hits, 0 excluded, 33 confirmed

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

United Kingdom9 confirmed, 1 excluded

Brazil30 confirmed, 1 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: ALIFAX SRL · ALIFAX S.R.L.

Regulatory identity

EU manufacturer SRN: IT-MF-000030029
UK responsible person: Advena Ltd

Business registration

LEI: 815600FA4D46A2C5FD13
Registration status: Active
Legal form: Società A Responsabilità Limitata (SRL)
Incorporated: 2008-10-30
Registered address: VIA PETRARCA, 2/1, POLVERARA, 35020
Registration authority: Business Register, no. 04337640280
Registry record updated: 2026-08-25

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08056040140048	LATEX CALIBRATORS	IVD A
EU	08056040149362	Reference Solution	IVD A
EU	08056040149379	ROLLER 20	IVD A
EU	08056040143407	ROLLER 20	IVD A
UK	56691	TEST1 BCL	IVD general
UK	56691	JO-PLUS	IVD A
UK	55971	LATEX CALIBRATORS	IVD A
BR	81816720000	FAMÍLIA DE ANALISADORES AUTOMÁTICOS PARA CULTURA DE MICRO-ORGANISMOS	Class II
BR	81816720002	Família de Teste de Suscetibilidade Antimicrobiana EUCAST	Class II
BR	81816720003	FAMÍLIA DE ANALISADORES AUTOMÁTICOS PARA VELOCIDADE DE HEMOSSEDIMENTAÇ	Class II
CA	82098	ALFRED 60 ANALYZER	Class II
CA	82933	URO-QUICK R.A.A. KIT	Class II
CA	83389	HB&L R.A.A. KIT	Class II

Alifax S.r.l.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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