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AXIOM Gesellschaft für Diagnostica und Biochemica mbH

Germany · Bürstadt · www.axiom-solutions.de

✓ Record-verifiedregistrations found in 8 marketsEU SRN DE-MF-000025590

This company has registrations in European Union, United Kingdom, Brazil, Canada, Taiwan, Singapore, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥56, 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

≥56UDI-DI device records

IVD A 47IVD B 3IVD C 6

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

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

43registered device records

IVD general 40IVD Annex II List A 1IVD Annex II List B 2

BRBrazilANVISA

15registered devices

Class II 15

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

38valid device licences

Class I 6Class II 32

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

77active registrations

Class 1 31Class 2a 39Class 2b 6Class 3 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 Union323 raw hits, 244 excluded, 56 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom43 confirmed, 1 excluded

Brazil15 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: HUMAN GESELLSCHAFT FUR BIOCHEMICA UND DIAGNOSTICS MBH · HUMAN GESELLSCHAFT FÜR BIOCHEMICA UND DIAGNOSTICA GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000025590
UK responsible person: Medscience distribution Ltd

Business registration

Legal name: Human Gesellschaft für Biochemica und Diagnostica mbH
LEI: 529900MXLS9YN52FBQ30
Registration status: Active
Legal form: Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated: 1972-12-05
Registered address: Max-Planck-Ring 21, Wiesbaden, 65205
Registration authority: Commercial Register, no. HRB 10782
Registry record updated: 2025-11-14

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04033145164869	HuMax HCT	IVD A
EU	04033145194248	AutoHumaPette 20-200µl	IVD A
EU	04033145164562	HuMax HCT	IVD A
EU	04033145215226	HumaNex A1c Variant Reagent	IVD A
UK	55981	HEMOSTAT APTT-EL	IVD general
UK	52925	GPT (ALAT) IFCC MOD. LIQUIUV HUMASTAR 2	IVD general
UK	53599	ALBUMIN LIQUICOLOR HUMASTAR	IVD general
BR	10303460438	Turbidos	Class II
BR	10303460461	HumaMeter A1c	Class II
BR	10303460566	Família de Analisadores Semi-Automáticos de Urina	Class II

AXIOM Gesellschaft für Diagnostica und Biochemica mbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

Registration details (sample)

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