Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

4580

FEI Number

4580

Entity Name

MACHEREY-NAGEL GMBH & CO., KG.

City/State/Country

DUEREN North Rhine-Westphalia, DE

Establishment Address

Valencienner Str. 11, DUEREN North Rhine-Westphalia 52355, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MACHEREY-NAGEL GMBH & CO. KG. (Owner Number: 9016893)

Owner / Operator Contact Address

Valencienner Str. 11, --, DUEREN, DE-NOTA 52355, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2005-12-21
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2005-12-21
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2005-12-21
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2005-12-21
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2005-12-21
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2005-12-21
JIP	Blood, Occult, Enzymatic Method, In Urine	Hematology	Class 2	864.6550	2005-12-21
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2005-12-21
KSL	Solution, Copper Sulfate For Specific Gravity Determinations	Hematology	Class 1	864.9320	2005-12-21
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2005-12-21
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2005-12-21
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2005-12-21

Official Correspondent

Markus Meusel

US Agent Details

DAWN Russup Business: MACHEREY-NAGEL INC. Email: drussup@mn-net.com Phone: (484) 8210984

Related Public Records

Same Entity

MACHEREY-NAGEL GMBH & CO. KG.

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
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.

Similar Registrations

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3027225088	STARLING MEDICAL	Houston, TX, US
3002637618	Siemens Healthcare Diagnostics Inc	East Walpole, MA, US
1832816	ARKRAY FACTORY USA, INC.	Miami, FL, US
3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN
3005360469	ACRO BIOTECH Inc.	Montclair, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 4580. Last updated year: 2026. Please use registration number 4580 when referencing this establishment in official correspondence.