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MP Diagnostics ASSURE HEV lgM Rapid Test

MP Diagnostics ASSURE HEV lgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000702
Basic UDI-DI: B-08887581000702
Reference: 43160-020
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics MULTISURE HIV Rapid Test

MP Diagnostics MULTISURE HIV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000665
Basic UDI-DI: B-08887581000665
Reference: 43030-020
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

MP Diagnostics HBsAg ELISA 4.1

23470-096 (96 wells)

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: MP Biomedicals Asia Pacific Pte Ltd
Manufacturer SRN: SG-MF-000024819
UDI-DI: 08887581000610
Basic UDI-DI: B-08887581000610
Reference: 23470-096
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: MP Biomedicals Germany GmbH
Last updated: 04.08.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

RevoDx Influenza A&B qPCR Kit

RevoDx Influenza A&B qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717387
Basic UDI-DI: B-08683079717387
Reference: IP202220-500
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:22

Manufacturer products View details

RevoDx Influenza A&B qPCR Kit

RevoDx Influenza A&B qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717370
Basic UDI-DI: B-08683079717370
Reference: IP202220-100
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:22

Manufacturer products View details

H. pylori Ag MonlabTest

MO-804001 25 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: MONLAB SL
Manufacturer SRN: ES-MF-000001438
UDI-DI: 08436539090496
Basic UDI-DI: B-08436539090496
Reference: MO-804001
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 04:25

Manufacturer products View details

ViraxClear Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo)

Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246461076
Basic UDI-DI: B-06974246461076
Reference: FCRA-6052
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test

SARS-CoV-2 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277517737
Basic UDI-DI: B-06970277517737
Reference: INCP-502
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Croatia
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Rapid Test Cassette

Influenza A+B Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277515269
Basic UDI-DI: B-06970277515269
Reference: IIN-R502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine)

Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277514644
Basic UDI-DI: B-06970277514644
Reference: ISLC-125
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:47

Manufacturer products Authorised representative products Authorised representative actors View details

MONO Rapid Test Cassette

MONO Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277513289
Basic UDI-DI: B-06970277513289
Reference: IMO-402
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test Cassette

Syphilis Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277511162
Basic UDI-DI: B-06970277511162
Reference: ISY-302
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Rapid Test Cassette

Influenza A+B Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277511063
Basic UDI-DI: B-06970277511063
Reference: IIN-502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

Strep A Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277510479
Basic UDI-DI: B-06970277510479
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test

FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804838805
Basic UDI-DI: B-06952804838805
Reference: MI-S46001
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Test (Colloidal Gold)

HCG Pregnancy Test (Colloidal Gold)

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062777823
Basic UDI-DI: B-06952062777823
Reference: HCG3UST-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

COVID-19 (SARS-CoV-2) Antigen Test Kit

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062774235
Basic UDI-DI: B-06952062774235
Reference: SL030101NST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva

COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)- Saliva

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062774112
Basic UDI-DI: B-06952062774112
Reference: SL030101SST-X
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf/pan Test Kit

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062773108
Basic UDI-DI: B-06952062773108
Reference: MPf/Pan1W-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria pf Test Kit

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062772989
Basic UDI-DI: B-06952062772989
Reference: MPf1W-25
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.08.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details