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Malaria P.f./P.v. Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000020377
UDI-DI: D-MALAC1-023G
Basic UDI-DI: B-MALAC1-023G
Reference: MALAC1-02
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f. Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MAL-D02aBL
Basic UDI-DI: B-MAL-D02aBL
Reference: MAL-D02a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 04:52

Manufacturer products Authorised representative products Authorised representative actors View details

Quik-Check

Quik-Check Syphilis Rapid Test Cassette (Serum/Plasma/Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-L031-10627J4
Basic UDI-DI: B-L031-10627J4
Reference: L031-10627
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Flowflex

Flowflex Syphilis Rapid Test Cassette (Serum/Plasma/Whole Blood)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-L031-10445HU
Basic UDI-DI: B-L031-10445HU
Reference: L031-10445
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-L-D22a43
Basic UDI-DI: B-L-D22a43
Reference: L-D22a
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Crypto/Giardia CEL IFA

Crypto/Giardia CEL IFA (50T)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Cellabs Pty Ltd
Manufacturer SRN: AU-MF-000030640
UDI-DI: D-KR2DD
Basic UDI-DI: B-KR2DD
Reference: KR2
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Italy
Authorised representative: WMDE B.V.
Last updated: 14.07.2026 03:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90507ZK

Influenza A&B Antigen Test kit(Colloidal Gold Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90507ZK
Basic UDI-DI: B-K90507ZK
Reference: /
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Rapid Test Cassette (Feces)

IrHPG6002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IrHPG6009G
Basic UDI-DI: B-IrHPG6009G
Reference: IrHPG6002
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

50 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-50tBT
Basic UDI-DI: B-IVD53-02-50tBT
Reference: IVD53-02-50t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

20 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-20tBC
Basic UDI-DI: B-IVD53-02-20tBC
Reference: IVD53-02-20t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

1 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-1tH5
Basic UDI-DI: B-IVD53-02-1tH5
Reference: IVD53-02-1t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

10 tests/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-IVD53-02-10tB7
Basic UDI-DI: B-IVD53-02-10tB7
Reference: IVD53-02-10t
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-ITB-402SL

ITB-402

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-ITB-402SL
Basic UDI-DI: B-ITB-402SL
Reference: ITB-402
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-ISY-U401RL

ISY-U401

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-ISY-U401RL
Basic UDI-DI: B-ISY-U401RL
Reference: ISY-U401
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-ISY-8032V

Syphilis Rapid Test (Oral Fluid)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISY-8032V
Basic UDI-DI: B-ISY-8032V
Reference: ISY-803
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-IST-502YJ

IST-502

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IST-502YJ
Basic UDI-DI: B-IST-502YJ
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-IST-501YG

IST-501

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IST-501YG
Basic UDI-DI: B-IST-501YG
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ISCOVu005G
Basic UDI-DI: B-ISCOVu005G
Reference: ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Hungary
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-IRTC-5X5(SSW)X7

Multiplex Respiratory Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTC-5X5(SSW)X7
Basic UDI-DI: B-IRTC-5X5(SSW)X7
Reference: IRTC-5X5(SSW)
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-INCP-RG502CE
Basic UDI-DI: B-INCP-RG502CE
Reference: INCP-RG502
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details