Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034211429

FEI Number

3034211429

Entity Name

ALGODX AB

City/State/Country

Stockholm, SE

Establishment Address

Gotgatan 22A, Stockholm 118 46, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AlgoDx AB (Owner Number: 10092080)

Owner / Operator Contact Address

PO Box 559173-7985, Stockholm, SE-AB 106 31, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240558

PMA Number

N/A

All Registered Proprietary Names

NAVOYCDS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PLB	Multivariate Vital Signs Index	Cardiovascular	Class 2	870.2300	2024-12-03

Official Correspondent

Andreas Macura

US Agent Details

David Becedas Business: AlgoDx LLC Email: regulatory@algodx.com Phone: (617) 4590473

Related Public Records

Same Entity

AlgoDx 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 3034211429. Last updated year: 2026. Please use registration number 3034211429 when referencing this establishment in official correspondence.