Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028170577

FEI Number

3028170577

Entity Name

ONETWO ANALYTICS AB

City/State/Country

Stockholm, SE

Establishment Address

Kungsgatan 84, Stockholm 112 27, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OneTwo Analytics AB (Owner Number: 10088626)

Owner / Operator Contact Address

Kungsgatan 84, Stockholm, SE-AB S-112 27, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OneTwo Prio OneTwo Insights OneTwo Diabetes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software	Clinical Chemistry	Class 1	862.2120	2023-09-07

Official Correspondent

No official correspondent registered.

US Agent Details

Lee Leichter Business: P/L Biomedical Email: leichter@plbiomedical.com Phone: (239) 9946488

Related Public Records

Same Entity

OneTwo Analytics AB

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 3028170577. Last updated year: 2026. Please use registration number 3028170577 when referencing this establishment in official correspondence.