Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006988008

FEI Number

3006988008

Entity Name

ALIFAX SRL

City/State/Country

Nimis Udine, IT

Establishment Address

Via Merano 30, Nimis Udine 33045, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALIFAX SRL (Owner Number: 10035224)

Owner / Operator Contact Address

Via Francesco Petrarca 2/1, Polverara, IT-PD 35020, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SI 195.210/THL TEST1 2 SI 305.302-A LATEX CONTROLS (30 TESTS) SI 305.400-A LATEX CALIBRATORS SI 305.300-A LATEX CONTROLS (30 TESTS) SI 804.100 JO-PLUS SI 305.402-A LATEX CALIBRATORS SI R20-MC ROLLER 20 SI 305.102-A LATEX CONTROLS (6 TESTS) SI 305.100-A LATEX CONTROLS (6 TESTS) SI R20-PN ROLLER 20

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	2011-02-14

Official Correspondent

Camillo Galiano

US Agent Details

Lorenzo Da Madice Business: ISOPLAN USA Email: isoplan@fda-510k.com Phone: (386) 8680618

Related Public Records

Same Entity

ALIFAX SRL

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006988008. Last updated year: 2026. Please use registration number 3006988008 when referencing this establishment in official correspondence.