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80 device results listed.

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Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO114R5
Basic UDI-DI: B-DCOD-ACO114R5
Reference: DCOD-ACO114
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO111QX
Basic UDI-DI: B-DCOD-ACO111QX
Reference: DCOD-ACO111
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO102QW
Basic UDI-DI: B-DCOD-ACO102QW
Reference: DCOD-ACO102
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO101QU
Basic UDI-DI: B-DCOD-ACO101QU
Reference: DCOD-ACO101
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

MOP Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DMO-R101(ACRO)WW
Basic UDI-DI: B-DMO-R101(ACRO)WW
Reference: DMO-R101
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

6-MAM Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DMA-R101(ACRO)EQ
Basic UDI-DI: B-DMA-R101(ACRO)EQ
Reference: DMA-R101
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:07

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

06941571828102

R28-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571828102
Basic UDI-DI: B-06941571828102
Reference: R28-112
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

06941571828003

R28-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571828003
Basic UDI-DI: B-06941571828003
Reference: R28-110
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

Opiate Saliva Test Card

1L11C5

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711236
Basic UDI-DI: B-06921963711236
Reference: 1L11C5
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Opiate-2000 Test Strip

1L12S3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963710246
Basic UDI-DI: B-06921963710246
Reference: 1L12S3
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:54

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Opiate-2000 Test Card

1L12C3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963710239
Basic UDI-DI: B-06921963710239
Reference: Rapid Opiate-2000 Test Card
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:54

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Opiate Test Strip

1L11S3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963710222
Basic UDI-DI: B-06921963710222
Reference: 1L11S3
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:54

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Opiate Test Card

1L11C3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963710215
Basic UDI-DI: B-06921963710215
Reference: 1L11C3
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-DOP-102S9

Opiates (OPI) Rapid Test Cassette (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-DOP-102S9
Basic UDI-DI: B-DOP-102S9
Reference: DOP-102
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

D-A062D5

INDICAID™ Fentanyl Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A062D5
Basic UDI-DI: B-A062D5
Reference: INDICAID™ Fentanyl Rapid Test
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A059DG

INDICAID™ Morphine Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A059DG
Basic UDI-DI: B-A059DG
Reference: INDICAID™ Morphine Rapid Test
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

Opiate(OPI) Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646OPI001MX5F
Basic UDI-DI: B-697424646OPI001MX5F
Reference: OPI-1011/OPI-1012/OPI-1014
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Opiate(OPI) Rapid Test Kit(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646OPI000MV56
Basic UDI-DI: B-697424646OPI000MV56
Reference: OPI-1011/OPI-1012/OPI-1014
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Morphine Heroin(MOR) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MOR001NR74
Basic UDI-DI: B-697424646MOR001NR74
Reference: MOP-1011/MOP-1012/MOP-1014
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:09

Manufacturer products Authorised representative products Authorised representative actors View details