Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010739981

FEI Number

3010739981

Entity Name

BIOPORTO DIAGNOSTICS A/S

City/State/Country

Hellerup Hovedstaden, DK

Establishment Address

Tuborg Havnevej, 15, st, Hellerup Hovedstaden 2900, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioPorto Diagnostics A/S (Owner Number: 10089659)

Owner / Operator Contact Address

Tuborg Havnevej, 15, st, Hellerup, DK-84 2900, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232761

PMA Number

N/A

All Registered Proprietary Names

ProNephro AKI (NGAL)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PIG	Acute Kidney Injury Test System	Clinical Chemistry	Class 2	862.1220	2023-12-27

Official Correspondent

Monika Bak

US Agent Details

Jennifer Zonderman Business: BioPorto Diagnostics Inc. Email: jmz@bioporto.com Phone: (617) 6942918

Related Public Records

Same Entity

BioPorto Diagnostics A/S

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 3010739981. Last updated year: 2026. Please use registration number 3010739981 when referencing this establishment in official correspondence.