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Advanced Molecular Diagnostics Ltd.

United Kingdom of Great Britain and Northern Ireland · Nottingham · www.am-diagnostics.co.uk

✓ Record-verifiedregistrations found in 3 marketsEU SRN UK-MF-000043044

This company has registrations in European Union, United States, United Kingdom — 3 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

37UDI-DI device records

IVD general 37

USUnited StatesFDA openFDA

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

53registered device records

IVD general 53

BRBrazilANVISA

0registered devices

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 Union173 raw hits, 136 excluded, 37 confirmed

United States0 registration records, 1 510(k), 0 PMA, 30 excluded

United Kingdom53 confirmed, 8 excluded

Brazil0 confirmed, 13 excluded

Canada0 confirmed, 7 excluded

Regulatory identity

EU manufacturer SRN: UK-MF-000043044
EU authorised representative: Advena Limited

Business registration

Legal name: ADVANCED MOLECULAR DIAGNOSTICS LTD
Company number: 10730627
Registration status: Active
Legal form: Private Limited Company
Incorporated: 2017-04-19
Principal activity: 32500 - Manufacture of medical and dental instruments and supplies
Registered address: BIOCITY, NOTTINGHAM, NG1 1GF

Business registration data from UK Companies House, 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	05061059980649	—	IVD general
EU	05061059980625	—	IVD general
EU	05061059980588	—	IVD general
EU	05061059980564	—	IVD general
UK	49863	ZENA MAX Adenovirus Real-Time PCR Detection Kit	IVD general
UK	59291	ZENA MAX HLA B27 Real-Time PCR Detection Kit	IVD general
UK	62536	ZENA MAX Colistin Resistance	IVD general
US	K013258	INPATH E2 COLLECTOR	2002-05-31

Advanced Molecular Diagnostics Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

Registration details (sample)

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