ELITechGroup S.p.A.

FDA Device Registration & Listing · Torino Piedmont, IT · Registration 3011461582

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011461582
FEI Number
3011461582
Entity Name
ELITechGroup S.p.A.
City/State/Country
Torino Piedmont, IT
Establishment Address
Corso Svizzera 185, Torino Piedmont 10149, IT
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ELITechGroup Inc. (Owner Number: 1717966)
Owner / Operator Contact Address
370 West 1700 South, Logan, UT 84321, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180559
PMA Number
N/A

All Registered Proprietary Names

Elite InGenius Elite InGenius SP 200 Elite InGenius SP 200 Consumable Elite InGenius Waste Box Elite InGenius PCR Cassette

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2018-12-05
PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples Microbiology Class 2 866.3309 2018-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Ortiz Business: ELITechGroup Inc. Email: robert.ortiz@elitechgroup.com Phone: (435) 7526011

Related Public Records

Same Entity

ELITechGroup Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3044320359 ELITechGroup Inc., Tucson Tucson, AZ, US
3003540236 ELITechGroup MDX LLC. Bothell, WA, US
3006091463 ELITechGroup MICROBIO SIGNES Var, FR
1717966 ELITechGroup Inc LOGAN, UT, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011461582. Last updated year: 2026. Please use registration number 3011461582 when referencing this establishment in official correspondence.
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