Alifax S.r.l.
Italy IT-MF-000030029 Last updated 21 Oct 2026
- Devices
- 22
- Registries
- EUDAMEDGUDID
- FDA recalls
- 0
Catalogue
M-Shaker Ref SI 2301.100
Washing Solution Ref SI105248
Mm Gram Pos Staph Ref SI 1701.0103/L
Molecular Mouse System Ref SI 1701.100/I
Mm Gram Pos No Staph Ref SI 1701.0104/L
Mm Gram Pos Staph Ref SI 1701.0103/5L
Reference Solution Ref SI16029501
Hb&L Carbapenemase Kit Ref SI 1001.950
Mm Gram Pos No Staph Ref SI 1701.0104/5L
M-Smasher Kit Ref SI 2301.210
Hb&L Esbl Screening Kit Ref SI 1001.930-L
Mm Gram Neg Res Ref SI 1701.0101/5L
Hb&L Vre Kit Ref SI 1001.910-L
Mm Gram Neg Res Ref SI 1701.0101/L
Molecular Mouse Ref SI 1701.900/I
Sidecar Ref SI 0807.100
Pen Ok Ref SI 0903.900
Roller 20 Ref SI R20-LC
M-Smasher Kit Ref SI 2301.200
Mm Gram Neg Id Ref SI 1701.0102/5L
Mm Gram Neg Id Ref SI 1701.0102/L
Hb&L Mrsa Kit Ref SI 1001.900-L
EUDAMED certificates
QMD Services GmbH 2962 1 certificate
- IQMS/00005/0v003 Supplemented
Quality management system EU IVDR
- Issued
- 11 Aug 2026
- Expires
- 23 Nov 2030
- Reason
- Add device or group
Related companies
Notified bodies
- QMD Services GmbH 2962
About
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What Alifax S.r.l. makes
Alifax S.r.l. manufactures in vitro diagnostic (IVD) devices for microbiological testing, including the MM GRAM NEG ID for identifying Gram-negative bacteria and the HB&L MRSA KIT for detecting methicillin-resistant *Staphylococcus aureus* (MRSA). These products are designed for laboratory use to support bacterial identification and antibiotic resistance screening.
The company’s portfolio is classified under EU Class C in vitro diagnostic medical devices and is registered in the EU’s eudamed database. Alifax S.r.l. is based in Italy and adheres to EU regulatory requirements for IVD devices.
Frequently asked questions
What types of medical devices does Alifax S.r.l. manufacture?
Alifax S.r.l. specializes in in vitro diagnostic (IVD) devices used in microbiological testing. Specifically, their portfolio includes products like the MM GRAM NEG ID, which helps identify Gram-negative bacteria, and the HB&L MRSA KIT, designed to detect methicillin-resistant *Staphylococcus aureus* (MRSA). These devices are intended for laboratory environments to aid in bacterial identification and antibiotic resistance screening.
Where is Alifax S.r.l. based, and what regulatory requirements do they follow?
Alifax S.r.l. is based in Italy. Their devices are developed in compliance with EU regulatory standards for in vitro diagnostic medical devices, ensuring they meet the necessary requirements for safety, performance, and quality. This includes adherence to EU IVD classification rules and registration in the EU’s eudamed database.
Which regulatory registries list Alifax S.r.l.’s devices?
Alifax S.r.l.’s in vitro diagnostic devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration confirms their compliance with EU regulatory requirements for IVDs, including classification and traceability.
How are Alifax S.r.l.’s devices classified under EU regulations?
Alifax S.r.l.’s devices fall under EU Class C for in vitro diagnostic medical devices. This classification is determined based on the risk associated with the device’s intended use—Class C includes higher-risk IVDs, such as those used for detecting significant pathogens like MRSA, where accurate results directly impact patient management.
Information
- Country
- Italy
- Address
- 30, Via Merano, Nimis, Italy
- Website
- www.alifax.com
- [email protected]
- Phone
- +39 0490992000
- PRRC contact
- Eleonora Marini
- EUDAMED SRN
- IT-MF-000030029