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MACHEREY-NAGEL GmbH & Co. KG

Germany · Düren · www.mn-net.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN DE-MF-000005636

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

89UDI-DI device records

IVD A 12IVD B 71IVD C 6

USUnited StatesFDA openFDA

15listed device types

Class I 12Class II 3Class III 0

plus 3 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

4registered device records

IVD A 2IVD B 1IVD general 1

BRBrazilANVISA

12registered devices

Class I 6Class II 6

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IVD Class 2 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union89 raw hits, 0 excluded, 89 confirmed

United States3 registration records, 3 510(k), 0 PMA

United Kingdom4 confirmed, 0 excluded

Brazil12 confirmed, 0 excluded

Manufacturer names merged into this page: MACHEREY-NAGEL GMBH & CO., KG. · MACHEREY-NAGEL GMBH & CO. KG · MACHEREY NAGEL GMBH & CO KG

Regulatory identity

EU manufacturer SRN: DE-MF-000005636
UK responsible person: QCS International LTD.

FDA 510(k) clearances by year

11999 · K991927

12005 · K051034

12006 · K061742

FDA listed device types

showing 8 of 15

Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) 1Dye-Indicator, Ph (Urinary, Non-Quantitative) 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Automated Urinalysis System 1Solution, Copper Sulfate For Specific Gravity Determinations 1Test, Urine Leukocyte 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04046681152962	pH-Fix 2.0 - 9.0 PT	IVD B
EU	04046681171727	Medi-Test Combi 2	IVD B
EU	04046681006326	NucleoSpin® Dx Virus	IVD A
EU	04046681141683	URYXXON® Control Strip	IVD A
UK	30219	Medi-Test Control	IVD B
UK	54514	MEDI-TEST Combi 10 SGL	IVD general
UK	52521	NucleoMag DX Pathogen	IVD A
US	K061742	URYXXON RELAX URINE ANALYZER	2006-09-06
US	K051034	URYXXON 200 URINE ANALYZER	2005-11-22
US	K991927	MEDI-TEST COMBI 11	1999-09-17
BR	81124120019	NucleoSpin Dx Virus	Class I
BR	81124120023	NucleoSpin Dx Blood	Class I
BR	81124120020	NucleoMag® Virus	Class I

MACHEREY-NAGEL GmbH & Co. KG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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