Home›Germany›Agilent Technologies GmbH

Agilent Technologies GmbH

Germany · Waldbronn · www.agilent.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN SG-MF-000014448

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 11 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

IVD A 156IVD C 29IVD general 113ivd-annex-ii-list-b 2

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

77listed device types

Class I 47Class II 22Class III 6unclassified 2

plus 277 registration records and 49 510(k), 108 PMA

UKUnited KingdomMHRA PARD

341registered device records

IVD A 44IVD C 17IVD general 273Class C – Companion Diagnostics 5IVD Annex II List B 2

BRBrazilANVISA

32registered devices

Class I 31Class II 1

90 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

339active device licences

Class II 335Class III 4

749 including historic records

TWTaiwanTFDA

15valid device licences

Class I 12Class III 3

SGSingaporeHSA SMDR

37device registrations

CLASS B 22CLASS C 15

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

25active ARTG entries

IVD Class 1 3IVD Class 2 14IVD Class 3 8

HKHong KongMDACS

76valid listings

IVD B 47IVD C 29

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 Union381 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States277 registration records, 49 510(k), 108 PMA

United Kingdom341 confirmed, 1 excluded

Brazil32 confirmed, 0 excluded

Canada339 confirmed, 0 excluded

Manufacturer names merged into this page: Agilent Technologies, Inc · Agilent Technologies Inc. · Agilent Technologies, Inc. · Agilent Technologies Singapore (International) Pte Ltd. · AGILENT TECHNOLOGIES, INC. · AGILENT TECHNOLOGIES DENMARK APS

Regulatory identity

EU manufacturer SRN: SG-MF-000014448
EU authorised representative: Agilent Technologies Denmark ApS
UK responsible person: Agilent Technologies LDA UK Limited

FDA 510(k) clearances by year

21982

21985

11989

11992

11994

11995

11998

21999

242000

132001

12017

FDA listed device types

showing 8 of 77

Counter, Differential Cell 1Calibrator, Secondary 1Kappa, Fitc, Antigen, Antiserum, Control 1Test, Cystatin C 1Immunohistochemistry Assay, Antibody, Progesterone Receptor 1Iga, Antigen, Antiserum, Control 1System, Test, Automated Blood Grouping And Antibody 1Immunohistochemistry Antibody Assay, Estrogen Receptor 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-SGMF000014448GA50061ZF	FLEX Polyclonal Rabbit Anti-Human Alpha-1-Fetoprotein, Ready-to-Use (Dako Omnis)	IVD general
EU	D-SGMF000014448IR78661CV	FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use (Link)	IVD general
EU	D-SGMF000014448IR78061BX	FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6, Clone D5/16 B4, Ready-to-Use (Link)	IVD general
EU	D-SGMF000014448IR77961D5	FLEX Monoclonal Mouse Anti-Human Placental Alkaline Phosphatase, Clone 8A9, Ready-to-Use (Link)	IVD general
UK	56766	Polyclonal Rabbit Anti-Human Albumin, Unconjugated, Ig fraction, Immunohistochemistry/Precipitation/Blot/ELISA, 2 mL	IVD general
UK	62973	Polyclonal Rabbit Anti-Human Orosomucoid (Alpha-1-Acid Glycoprotein), Unconjugated, Turbidimetry/Nephelometry, 5 mL	IVD general
UK	62767	FLEX Polyclonal Rabbit Anti-Human Alpha-1-Antitrypsin, Ready-to-Use (Dako Omnis), Unconjugated, Packaged in vials for use with Dako Omnis, Immunohistochemistry, 60 tests, 12 mL	IVD general
US	K163367	GenetiSure Dx Postnatal Assay	2017-08-11
US	K010949	2010 PLUS HOLTER FOR WINDOWS	2001-09-28
US	K012094	MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A	2001-07-20
BR	80000230093	Hematoxylin (Dako Omnis)	Class I
BR	80000230094	EnVision FLEX Hematoxylin (Link)	Class I
BR	80000230078	PT LINK	Class I
CA	3921	MOUSE ANTI-HUMAN T-CELL (DAKO CD45RO,UCHL-1)	Class II
CA	3925	MOUSE ANTI-HUMAN T-CELL, CD2/MT910 FITC	Class II
CA	3947	DAKO PAP KIT RABBIT	Class II