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Multi-Drugs Rapid Test

VDMC-1288-001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMC-1288-001QZ
Basic UDI-DI: B-VDMC-1288-001QZ
Reference: VDMC-1288-001
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:16

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drugs Rapid Test Easy Cup

VDMC-1155-001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMC-1155-001N8
Basic UDI-DI: B-VDMC-1155-001N8
Reference: VDMC-1155-001
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:16

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drugs Rapid Test Cup 12

VDMC-1128-002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMC-1128-002N4
Basic UDI-DI: B-VDMC-1128-002N4
Reference: VDMC-1128-002
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:16

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drugs Rapid Test Cup

VDMC-1128-001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMC-1128-001N2
Basic UDI-DI: B-VDMC-1128-001N2
Reference: VDMC-1128-001
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:16

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drugs Rapid Test 1-Step Cup

VDMC-1108-002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMC-1108-002MA
Basic UDI-DI: B-VDMC-1108-002MA
Reference: VDMC-1108-002
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:16

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drugs Rapid Test Key Cup

VDKC-1108-001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDKC-1108-001KA
Basic UDI-DI: B-VDKC-1108-001KA
Reference: VDKC-1108-001
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:15

Manufacturer products Authorised representative products Authorised representative actors View details

SOMA One Step Carisoprodol Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SOMA-A01aFT
Basic UDI-DI: B-SOMA-A01aFT
Reference: SOMA-A01a, SOMA-A01b
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Metomidate (MTO) Rapid Test Panel

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-MTO-4-AZS
Basic UDI-DI: B-MTO-4-AZS
Reference: MTO-4-A
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

Metomidate (MTO) Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-MTO-2-AZG
Basic UDI-DI: B-MTO-2-AZG
Reference: MTO-2-A
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

Metomidate (MTO) Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-MTO-1-AZB
Basic UDI-DI: B-MTO-1-AZB
Reference: MTO-1-A
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 05:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-MD-W42W415TT

Multi-drug Single-line Whole Blood Test Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-MD-W42W415TT
Basic UDI-DI: B-MD-W42W415TT
Reference: MD-W42~MD-W415
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-MD-S32S316QB

Multi-drug Saliva Test Stick

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-MD-S32S316QB
Basic UDI-DI: B-MD-S32S316QB
Reference: MD-S32~MD-S316
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-MD-S32S312Q3

Multi-drug Saliva Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-MD-S32S312Q3
Basic UDI-DI: B-MD-S32S312Q3
Reference: MD-S32~MD-S312
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-MD-U42U415SB

Multi-drug Single-line Urine Test Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-MD-U42U415SB
Basic UDI-DI: B-MD-U42U415SB
Reference: MD-U42~MD-U415
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-MD-S42S415QT

Multi-drug Single-line Saliva Test Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-MD-S42S415QT
Basic UDI-DI: B-MD-S42S415QT
Reference: MD-S42~MD-S415
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

LSD One Step Lysergic acid diethylamide Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-LSD-A01aGK
Basic UDI-DI: B-LSD-A01aGK
Reference: LSD-A01a
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

Drugs of Abuse Rapid Test Cassette (Hair)

GBXXX-1102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBXXX-1102HGN3
Basic UDI-DI: B-GBXXX-1102HGN3
Reference: GBXXX-1102
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Drugs of Abuse Test Dip Card (Urine)

GBXXX-105

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBXXX-105HGKK
Basic UDI-DI: B-GBXXX-105HGKK
Reference: GBXXX-105
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Drugs of Abuse Test Cassette (Urine)

GBXXX-102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBXXX-102HGK4
Basic UDI-DI: B-GBXXX-102HGK4
Reference: GBXXX-102
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Drugs of Abuse Test Strip (Urine)

GBXXX-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GBXXX-101HGJX
Basic UDI-DI: B-GBXXX-101HGJX
Reference: GBXXX-101
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details