Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003366417

FEI Number

3003366417

Entity Name

LRE MEDICAL GMBH

City/State/Country

NOERDLINGEN Bavaria, DE

Establishment Address

HOFER STRASSE 5, NOERDLINGEN Bavaria 86720, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LRE MEDICAL GMBH (Owner Number: 9049285)

Owner / Operator Contact Address

HOFER STRASSE 5, --, NOERDLINGEN, DE-BY 86720, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QIAstat-dx® Analyzer 1 Vivatmo pro TRIAGE METER CT ExpresTM 3D Contrast Media Delivery System UCHECK ACCUCHECK INSTAND PLUS DUAL TESTING ACCUCHECK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2019-05-22
MXA	System, Test, Breath Nitric Oxide	Clinical Toxicology	Class 2	862.3080	2024-05-16
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-02-24
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2006-05-08
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2006-05-08
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2006-05-08
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2006-05-08
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2017-11-02
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2006-05-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2006-05-08
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2006-05-08

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

LRE MEDICAL GMBH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171566	Siemens Healthcare Diagnostics, Inc.	Atellica IM High-Sensitivity Troponin I (TNIH)	2018-07-19
K182225	Siemens Healthcare Diagnostics, Inc.	Dimension Vista High-Sensitivity Troponin I (TNIH) Assay	2019-03-04
K790947	Macomb Chemical Co.	AUTO ENZYMATIC CHOLESTEROL	1979-06-28
K885023	Em Diagnostic Systems, Inc.	CHOLESTEROL TEST ITEM NUMBER: SR1011	1989-02-17
K771508	Instrumentation Laboratory CO	MULTISTAT III CHOLESTEROL TEST	1977-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0052-2021	Siemens Healthcare Diagnostics, Inc.	2	Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

Similar Registrations

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3004530258	CEPHEID	Sunnyvale, CA, US
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3016619649	Sansure Biotech Inc.	Changsha Hunan, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003366417. Last updated year: 2026. Please use registration number 3003366417 when referencing this establishment in official correspondence.