EUDAMED update: Sep 13, 2024

Alifax S.r.l.

IT-MF-000030029

Active29 devices

Address: Via Merano, 30 33045 Nimis
Role: Manufacturer
Date of registration: Oct 26, 2022
Country: Italy

Alifax S.r.l. is a medical device manufacturer registered in EUDAMED. The company has 29 devices on the EU market across 28 countries. It holds 1 valid CE certificate. Headquartered in Nimis, Italy. Explore the regulatory profile, devices and certificates on MD Atlas.

About Alifax

: IT-MF-000030029
Role: Manufacturer
Country: Italy
Organization name: Alifax S.r.l.
EU VAT number: 04337640280
EORI: 04337640280
Date of registration: Oct 26, 2022

Contact details for Alifax

Phone: +39 0490992000
Email: regulatory@alifax.com
Website: www.alifax.com
Address: 30, VIA MERANO 33045 NIMIS ITALY

Data export

Export the 29 devices of Alifax

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Competent authority

Name: Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico

Phone: +39 06 5994 3199/ +39 06 5994 3207
Email: segr.dgfdm@sanita.it

Officers and regulatory representatives of Alifax

FALCONE Francesco
ensuring items set forth in Article 15, par. 3, letters a and d of Regulation (EU) 2017/746, notably that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (d) the reporting obligations referred to in Articles 82 to 86 are fulfilled.
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MARINI Eleonora
ensuring items set forth in Article 15, par. 3, letters b, c and e of Regulation (EU) 2017/746, notably that: b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(9); (e) in the case of devices for performance studies intended [...], the statement referred to in Section 4.1 of Annex XIV is issued.
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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
ALFRED 60	ALFRED 60	`SI 105.100`	`08056040140291`	1	On the market
HB&L CARBAPENEMASE KIT	HB&L CARBAPENEMASE KIT	`SI 1001.950`	`08056040149300`	1	On the market
HB&L ESBL SCREENING KIT	HB&L ESBL SCREENING KIT	`SI 1001.930-L`	`08056040149430`	1	On the market
HB&L MRSA KIT	HB&L MRSA KIT	`SI 1001.900-L`	`08056040149287`	60	On the market
HB&L UROQUATTRO	HB&L UROQUATTRO	`SI 190.300`	`08056040140307`	1	On the market
HB&L UROQUATTRO LIGHT	HB&L UROQUATTRO LIGHT	`SI 190.300L`	`08056040141502`	1	On the market
HB&L VRE KIT	HB&L VRE KIT	`SI 1001.910-L`	`08056040149294`	1	On the market
LATEX CALIBRATORS	LATEX CALIBRATORS	`SI 305.400-A`	`08056040141236`	1	On the market
LATEX CONTROLS	LATEX CONTROLS	`SI 305.100-A`	`08056040141212`	1	On the market
M-SHAKER	M-SHAKER	`SI 2301.100`	`08056040149164`	1	On the market
M-SMASHER KIT	M-SMASHER KIT	`SI 2301.210`	`08056040149188`	1	On the market
M-SMASHER KIT	M-SMASHER KIT	`SI 2301.200`	`08056040149171`	1	On the market
MM GRAM NEG ID	MM GRAM NEG ID	`SI 1701.0102/L`	`08056040149249`	1	On the market
MM GRAM NEG ID	MM GRAM NEG ID	`SI 1701.0102/5L`	`08056040149201`	1	On the market
MM GRAM NEG RES	MM GRAM NEG RES	`SI 1701.0101/5L`	`08056040149232`	1	On the market
MM GRAM NEG RES	MM GRAM NEG RES	`SI 1701.0101/L`	`08056040149331`	1	On the market
MM GRAM POS NO STAPH	MM GRAM POS NO STAPH	`SI 1701.0104/5L`	`08056040149225`	1	On the market
MM GRAM POS NO STAPH	MM GRAM POS NO STAPH	`SI 1701.0104/L`	`08056040149263`	1	On the market
MM GRAM POS STAPH	MM GRAM POS STAPH	`SI 1701.0103/L`	`08056040149256`	1	On the market
MM GRAM POS STAPH	MM GRAM POS STAPH	`SI 1701.0103/5L`	`08056040149355`	1	On the market
MOLECULAR MOUSE	MOLECULAR MOUSE	`SI 1701.900/I`	`08056040145463`	1	On the market
MOLECULAR MOUSE SYSTEM	MOLECULAR MOUSE SYSTEM	`SI 1701.100/I`	`08056040148471`	1	On the market
POSITIVE CONTROL KIT	POSITIVE CONTROL KIT	`SI 190.911`	`08056040141168`	1	On the market
ROLLER 20	ROLLER 20	`SI R20-MC`	`08056040143407`	1	On the market
ROLLER 20	ROLLER 20	`SI R20-LC`	`08056040149362`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
ALFRED 60	ALFRED 60	`SI 105.100`	`08056040140291`	1	On the market
HB&L CARBAPENEMASE KIT	HB&L CARBAPENEMASE KIT	`SI 1001.950`	`08056040149300`	1	On the market
HB&L ESBL SCREENING KIT	HB&L ESBL SCREENING KIT	`SI 1001.930-L`	`08056040149430`	1	On the market
HB&L MRSA KIT	HB&L MRSA KIT	`SI 1001.900-L`	`08056040149287`	60	On the market
HB&L UROQUATTRO	HB&L UROQUATTRO	`SI 190.300`	`08056040140307`	1	On the market
HB&L UROQUATTRO LIGHT	HB&L UROQUATTRO LIGHT	`SI 190.300L`	`08056040141502`	1	On the market
HB&L VRE KIT	HB&L VRE KIT	`SI 1001.910-L`	`08056040149294`	1	On the market
LATEX CALIBRATORS	LATEX CALIBRATORS	`SI 305.400-A`	`08056040141236`	1	On the market
LATEX CONTROLS	LATEX CONTROLS	`SI 305.100-A`	`08056040141212`	1	On the market
M-SHAKER	M-SHAKER	`SI 2301.100`	`08056040149164`	1	On the market
M-SMASHER KIT	M-SMASHER KIT	`SI 2301.210`	`08056040149188`	1	On the market
M-SMASHER KIT	M-SMASHER KIT	`SI 2301.200`	`08056040149171`	1	On the market
MM GRAM NEG ID	MM GRAM NEG ID	`SI 1701.0102/L`	`08056040149249`	1	On the market
MM GRAM NEG ID	MM GRAM NEG ID	`SI 1701.0102/5L`	`08056040149201`	1	On the market
MM GRAM NEG RES	MM GRAM NEG RES	`SI 1701.0101/5L`	`08056040149232`	1	On the market
MM GRAM NEG RES	MM GRAM NEG RES	`SI 1701.0101/L`	`08056040149331`	1	On the market
MM GRAM POS NO STAPH	MM GRAM POS NO STAPH	`SI 1701.0104/5L`	`08056040149225`	1	On the market
MM GRAM POS NO STAPH	MM GRAM POS NO STAPH	`SI 1701.0104/L`	`08056040149263`	1	On the market
MM GRAM POS STAPH	MM GRAM POS STAPH	`SI 1701.0103/L`	`08056040149256`	1	On the market
MM GRAM POS STAPH	MM GRAM POS STAPH	`SI 1701.0103/5L`	`08056040149355`	1	On the market
MOLECULAR MOUSE	MOLECULAR MOUSE	`SI 1701.900/I`	`08056040145463`	1	On the market
MOLECULAR MOUSE SYSTEM	MOLECULAR MOUSE SYSTEM	`SI 1701.100/I`	`08056040148471`	1	On the market
POSITIVE CONTROL KIT	POSITIVE CONTROL KIT	`SI 190.911`	`08056040141168`	1	On the market
ROLLER 20	ROLLER 20	`SI R20-MC`	`08056040143407`	1	On the market
ROLLER 20	ROLLER 20	`SI R20-LC`	`08056040149362`	1	On the market

Alifax S.r.l.

About Alifax

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Device catalog for Alifax

Device families (Basic UDI-DI) of Alifax