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MP Biomedicals Germany GmbH

Germany · Eschwege · www.mpbio.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN SG-MF-000024819

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 10 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

75UDI-DI device records

IVD A 6IVD general 55ivd-annex-ii-list-a 7ivd-devices-self-testing 7

USUnited StatesFDA openFDA

8listed device types

Class I 6Class II 1Class III 0unclassified 1

plus 11 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

5registered device records

IVD D 1IVD Annex II List A 4

BRBrazilANVISA

1registered devices

Class II 1

25 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

41active device licences

Class II 41

42 including historic records

TWTaiwanTFDA

10valid device licences

Class I 2Class II 1Class III 7

SGSingaporeHSA SMDR

18device registrations

CLASS B 2CLASS C 7CLASS D 9

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

10active ARTG entries

IVD Class 1 1IVD Class 2 2IVD Class 3 4IVD Class 4 3

HKHong KongMDACS

5valid listings

IVD D 5

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 Union81 raw hits, 6 excluded, 75 confirmed

United States11 registration records, 2 510(k), 0 PMA, 2 excluded

United Kingdom5 confirmed, 1 excluded

Brazil1 confirmed, 0 excluded

Canada41 confirmed, 1 excluded

Manufacturer names merged into this page: MP BIOMEDICALS DIAGNOSTICS DIVISION · MP Biomedicals Asia Pacific Pte Ltd · MP BIOMEDICALS, LLC DIAGNOSTICS DIVISION · MP BIOMEDICALS ASIA PACIFIC PTE. LTD. · MP BIOMEDICALS ASIA PACIFIC PTE. LTD · MP BIOMEDICALS DO BRASIL LTDA

Regulatory identity

EU manufacturer SRN: SG-MF-000024819
EU authorised representative: MP Biomedicals Germany GmbH
UK responsible person: Sterilab Services Ltd.

FDA 510(k) clearances by year

12006 · K051958

12017 · K162395

FDA listed device types

Radioimmunoassay, Gastrin 1Radioimmunoassay, Progesterone 1Radioimmunoassay, Estradiol 1Radioimmunoassay, Total Estrogens, Nonpregnancy 1Radioimmunoassay, Androstenedione 1Radioimmunoassay, Testosterones And Dihydrotestosterone 1Radioimmunoassay, Free Thyroxine 1Research Use Only/Immunology Devices 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08887581000269	MP Diagnostics Helico Blot 2.1	IVD general
EU	08887581000252	MP Diagnostics Helico Blot 2.1	IVD general
EU	08887581001020	MP Diagnostics HEV ELISA 4.0	IVD general
EU	08887581001235	MP Diagnostics ASSURE H. pylori Antigen Rapid Test	IVD general
UK	48453	HIV Blot 2.2	IVD Annex II List A
UK	48454	MULTISURE HIV Rapid Test	IVD Annex II List A
UK	48457	MP Diagnostics MULTISURE HIV 1/2 Confirmatory Test Controls	IVD Annex II List A
US	K162395	MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup	2017-06-02
US	K051958	MP RAPIDOXY TEST STRIP, MODEL 07RD-7073	2006-07-21
BR	80313210028	FAMÍLIA AUTOBLOT SYSTEM	Class II
CA	16397	DOUBLE ANTIBODY TESTOSTERONE 125I RIA KIT	Class II
CA	16398	IMMUCHEM DOUBLE ANTIBODY 11-DESOXYCORTISOL	Class II
CA	16400	RSL 125I HACTH	Class II