Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008629194

FEI Number

3008629194

Entity Name

BIOVICA INTERNATIONAL AB

City/State/Country

Uppsala, SE

Establishment Address

Uppsala Science Park, Dag Hammarskjolds vag 54 B, Uppsala 75237, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

BIOVICA International AB (Owner Number: 10085854)

Owner / Operator Contact Address

Uppsala Science Park, Dag Hammarskjolds vag 54 B, Uppsala, SE-C 75237, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202852

PMA Number

N/A

All Registered Proprietary Names

DiviTumTKa DiviTum

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QTE	Thymidine Kinase Activity	Immunology	Class 2	866.6010	2022-08-31

Official Correspondent

Rickard Boman

US Agent Details

Hector Tamburini Business: Biovica Inc. Email: hector.tamburini@biovica.com Phone: (858) 2306164

Related Public Records

Same Entity

BIOVICA International 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 3008629194. Last updated year: 2026. Please use registration number 3008629194 when referencing this establishment in official correspondence.