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123 device results listed.

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COVID-19 Antigen Rapid Test Cassette (Saliva)

ICOV7002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV700Z9
Basic UDI-DI: B-ICOV700Z9
Reference: ICOV7002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Nucleic Acid RT-PCR Test Kit

ICOV52Nb, ICOV52Na

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV52N32
Basic UDI-DI: B-ICOV52N32
Reference: ICOV52Nb, ICOV52Na
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM Rapid Test

ICOV4212

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV421Z2
Basic UDI-DI: B-ICOV421Z2
Reference: ICOV4212
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Neutralization Antibody Rapid Test Cassette (WB/S/P)

ICNA4002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV400YS
Basic UDI-DI: B-ICOV400YS
Reference: ICNA4002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/IgM Rapid Test

ICHI4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICHI421TS
Basic UDI-DI: B-ICHI421TS
Reference: ICHI4212
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Brucellosis IgG/IgM Rapid Test

IBRU4211, IBRU4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IBRU421ZF
Basic UDI-DI: B-IBRU421ZF
Reference: IBRU4211, IBRU4212
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Marijuana (K2) Rapid Tests

DKT1001, DKT1002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DKT100B9
Basic UDI-DI: B-DKT100B9
Reference: DKT1001, DKT1002
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP FIA

CfNT4002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-CfNT40094
Basic UDI-DI: B-CfNT40094
Reference: CfNT4002
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Opiates Rapid Test

DOPI1001, DOPI1002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DOPI100Y2
Basic UDI-DI: B-DOPI100Y2
Reference: DOPI1001, DOPI1002
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine Rapid Test (Saliva)

DCOT7001, DCOT7002, DCOT7004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DCOT700W6
Basic UDI-DI: B-DCOT700W6
Reference: DCOT7001, DCOT7002, DCOT7004
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

Tricyclic Antidepressants (TCA) Rapid Test

DTCA1001, DTCA1002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DTCA100TU
Basic UDI-DI: B-DTCA100TU
Reference: DTCA1001, DTCA1002
EMDN: W0102160510
EMDN description: TRICYCLIC ANTIDEPRESSANTS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Phencyclidine Rapid Test

DPCP1001, DPCP1002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DPCP100VH
Basic UDI-DI: B-DPCP100VH
Reference: DPCP1001, DPCP1002
EMDN: W0102160509
EMDN description: PHENCYCLIDINE - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Methadone Rapid Test

DMTD1001, DMTD1002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DMTD100XH
Basic UDI-DI: B-DMTD100XH
Reference: DMTD1001, DMTD1002
EMDN: W0102160507
EMDN description: METHADONE INCL. EDDP - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

MDMA (Ecstasy) Rapid Test

DMDM1001, DMDM1002, DMDM1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DMDM100TY
Basic UDI-DI: B-DMDM100TY
Reference: DMDM1001, DMDM1002, DMDM1004
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 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine Rapid Test

DCOT1001, DCOT1002, DCOT1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DCOT100V8
Basic UDI-DI: B-DCOT100V8
Reference: DCOT1001, DCOT1002, DCOT1004
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cocaine Rapid Test

DCOC1001, DCOC1002, DCOC1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DCOC100RH
Basic UDI-DI: B-DCOC100RH
Reference: DCOC1001, DCOC1002, DCOC1004
EMDN: W0102160506
EMDN description: COCAINE + COCAINE METABOLITES - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Benzodiazepines Rapid Test

DBZO7001, DBZO7002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DBZO100XH
Basic UDI-DI: B-DBZO100XH
Reference: DBZO7001, DBZO7002
EMDN: W0102160504
EMDN description: BENZODIAZEPINES - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Barbiturates Rapid Test

DBAR7001, DBAR7002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DBAR100PK
Basic UDI-DI: B-DBAR100PK
Reference: DBAR7001, DBAR7002
EMDN: W0102160503
EMDN description: BARBITURATES - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine Rapid Test

DAMP1001, DAMP1002, DAMP1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DAMP100SU
Basic UDI-DI: B-DAMP100SU
Reference: DAMP1001, DAMP1002, DAMP1004
EMDN: W0102160501
EMDN description: AMPHETAMINES - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Morphine Rapid Test

DMOP1001, DMOP1002, DMOP1004

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-DMOP100YE
Basic UDI-DI: B-DMOP100YE
Reference: DMOP1001, DMOP1002, DMOP1004
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:58

Manufacturer products Authorised representative products Authorised representative actors View details