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122 device results listed.

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Dengue NS1 Antigen Rapid Tests

IDAG4001, IDAG4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IDAG400R4
Basic UDI-DI: B-IDAG400R4
Reference: IDAG4001, IDAG4002
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B Antigen Combo Rapid Test

ICFq325, ICFq328

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICFq32GX
Basic UDI-DI: B-ICFq32GX
Reference: ICFq325, ICFq328
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B Antigen Combo Rapid Test

ICFq312, ICFq318

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICFq31GV
Basic UDI-DI: B-ICFq31GV
Reference: ICFq312, ICFq318
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test (Swab)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IADq00FE
Basic UDI-DI: B-IADq00FE
Reference: IADq001, IADq002, IADq008
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test (Feces)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IAD60075
Basic UDI-DI: B-IAD60075
Reference: IAD6001, IAD6002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Tramadol Rapid Test

DTRA1001 DTRA1002 DTRA1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DTRA100YZ
Basic UDI-DI: B-DTRA100YZ
Reference: DTRA1001 DTRA1002 DTRA1004
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Pregabalin Rapid Test

DPGB1001 DPGB1002 DPGB1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DPGB100TT
Basic UDI-DI: B-DPGB100TT
Reference: DPGB1001 DPGB1002 DPGB1004
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Methamphetamine Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DMET100VU
Basic UDI-DI: B-DMET100VU
Reference: DMET1001, DMET1002, DMET1004
EMDN: W0102160502
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

MDPV Rapid Test

DMDP1001 DMDP1002 DMDP1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DMDP100UM
Basic UDI-DI: B-DMDP100UM
Reference: DMDP1001 DMDP1002 DMDP1004
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Etomidate Rapid Test (Saliva)

DETO7002 DETO7003

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DETO700XL
Basic UDI-DI: B-DETO700XL
Reference: DETO7002 DETO7003
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Etomidate Rapid Test

DETO1002, DETO1004, DETO1007, DETO100B

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DETO100WN
Basic UDI-DI: B-DETO100WN
Reference: DETO1002, DETO1004, DETO1007, DETO100B
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug Test (Saliva)

DDOA7205,DDOA7305, DDOA7405,DDOA7505,DDOA7605,DDOA7707,DDOA7807,DDOA7907,DDOA7a07, DDOA7b07, DDOA7b65, DDOA7c07, etc.

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DDOA718SZ
Basic UDI-DI: B-DDOA718SZ
Reference: DDOA7205,DDOA7305, DDOA7405,DDOA7505,DDOA7605,DDOA7707,DDOA7807,DDOA7907,DDOA7a07, DDOA7b07, DDOA7b65, DDOA7c07, etc.
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI/Myoglobin/CK-MB FIA

CfMCT4312

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CfMCT431XV
Basic UDI-DI: B-CfMCT431XV
Reference: CfMCT4312
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer FIA

CfDDg002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CfDDg0097
Basic UDI-DI: B-CfDDg0097
Reference: CfDDg002
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Cassette (WB/S/P)

CTNI4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CTNI400ZB
Basic UDI-DI: B-CTNI400ZB
Reference: CTNI4002
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)

CMCT4312

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CMCT431VF
Basic UDI-DI: B-CMCT431VF
Reference: CMCT4312
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test

CCK4001 CCK4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CCK4006L
Basic UDI-DI: B-CCK4006L
Reference: CCK4001, CCK4002
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Rapid Test

YPCT4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-YPCT400A4
Basic UDI-DI: B-YPCT400A4
Reference: YPCT4002
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 08:12

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Rapid Test

YCRP40R1 YCRP40R2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-YCRP40RB6
Basic UDI-DI: B-YCRP40RB6
Reference: YCRP40R1 YCRP40R2
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 08:12

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Rapid Test

YCAL6001 YCAL6002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-YCAL6002P
Basic UDI-DI: B-YCAL6002P
Reference: YCAL6001 YCAL6002
EMDN: W0102160699
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 08:11

Manufacturer products Authorised representative products Authorised representative actors View details