Home›Germany›Immundiagnostik AG

Immundiagnostik AG

Germany · Bensheim · www.immundiagnostik.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN DE-MF-000020905

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Israel, Russia — 9 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 6IVD B 7IVD general 287

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

USUnited StatesFDA openFDA

10listed device types

Class I 7Class II 3Class III 0

plus 16 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

71registered device records

IVD A 7IVD B 5IVD general 54Class C – Self-testing or Near-patient Testing 1IVD Devices for Self-Testing 4

BRBrazilANVISA

98registered devices

Class I 14Class II 84

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

22 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 1 1IVD Class 2 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

13registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 Union478 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States16 registration records, 0 510(k), 0 PMA

United Kingdom71 confirmed, 0 excluded

Brazil98 confirmed, 0 excluded

Manufacturer names merged into this page: IMMUNDIAGNOSTIK AG · IMMUNDIAGNOSTIK, INC. · IMMUNDIAGNOSTIK

Regulatory identity

EU manufacturer SRN: DE-MF-000020905
UK responsible person: Qserve Group UK, Ltd.

FDA listed device types

showing 8 of 10

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin 1M. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase) 1Container, Specimen Mailer And Storage, Non-Sterile 1P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin 1N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin 1Retinol-Binding Protein, Antigen, Antiserum, Control 1Free Secretory Component, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04050598015326	IDKlia® XL	IVD A
EU	04050598015319	IDKlia® M	IVD A
EU	04050598012868	Hepcidin-25 Control Set	IVD B
EU	04050598012851	Hepcidin-25 Calibrator Set	IVD B
UK	38242	1,25-(OH)2-Vitamin D3/D2 Calibrator Set	IVD B
UK	38243	1,25-(OH)2-Vitamin D3/D2 Control Set	IVD B
UK	54485	1,25-(OH)2-Vitamin D3/D2 IDKenhance® ImmuPlate DIY LC-MS/MS	IVD B
BR	80464810759	IDKmonitor® Adalimumab free ADA ELISA	Class II
BR	80464810760	IDKmonitor® Adalimumab total ADA ELISA	Class II
BR	80464810681	Anti-ox-LDL ELISA	Class II

Immundiagnostik AG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

Similar companies