Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011080315

FEI Number

3011080315

Entity Name

NUMARES AG

City/State/Country

Regensburg Bavaria, DE

Establishment Address

Am BioPark 13, Regensburg Bavaria 93053, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Numares AG (Owner Number: 10088504)

Owner / Operator Contact Address

Am BioPark 13, Regensburg, DE-BY 93053, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210801

PMA Number

N/A

All Registered Proprietary Names

AXINON® LDL-p Test System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2023-08-04

Official Correspondent

Stefanie Dukorn

US Agent Details

Mohmed Ashmaig Email: ashmaig@marinabiolab.com Phone: (510) 5795802

Related Public Records

Same Entity

Numares AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2009	Roche Diagnostics Corp.	1	Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.

Similar Registrations

Registration Number	Establishment Name	Location
3013660430	High Technology, Inc.	North Attleboro, MA, US
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
1827821	HORIBA INSTRUMENTS INCORPORATED	Canton, MI, US
1319808	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
2247288	ALFA WASSERMANN	West Caldwell, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011080315. Last updated year: 2026. Please use registration number 3011080315 when referencing this establishment in official correspondence.