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Multi-Drug Test Panel (Urine)

Multi-Drug Test Panel (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910551
Basic UDI-DI: B-06974238910551
Reference: HMDR047
EMDN: W0102090215
EMDN description: TRICYCLIC ANTIDEPRESSANTS (TOTAL)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Cotinine (COT) Rapid Test (Saliva)

Cotinine (COT) Rapid Test (Saliva)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910544
Basic UDI-DI: B-06974238910544
Reference: NCOT050S
EMDN: W0102090108
EMDN description: COTININE
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Synthetic Marijuana (K2) Rapid Test (Urine)

Synthetic Marijuana (K2) Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910537
Basic UDI-DI: B-06974238910537
Reference: NK2045
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine (AMP) Rapid Test (Urine)

Amphetamine (AMP) Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910520
Basic UDI-DI: B-06974238910520
Reference: NAMP044
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Cocaine (COC) Rapid Test (Urine)

Cocaine (COC) Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910513
Basic UDI-DI: B-06974238910513
Reference: NCOC043
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Methamphetamine (MET) Rapid Test (Urine)

Methamphetamine (MET) Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910506
Basic UDI-DI: B-06974238910506
Reference: NMET042
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Opiates (OPI) Rapid Test (Urine)

Opiates (OPI) Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910490
Basic UDI-DI: B-06974238910490
Reference: NOPI041
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Marijuana (THC) Rapid Test (Urine)

Marijuana (THC) Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910483
Basic UDI-DI: B-06974238910483
Reference: NTHC040
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

ALC Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anbio (Xiamen) Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000023936
UDI-DI: 06973861683177
Basic UDI-DI: B-06973861683177
Reference: A11020002
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 17:41

Manufacturer products Authorised representative products Authorised representative actors View details

The Drug Rapid Test (Urine)

The Drug Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792054301
Basic UDI-DI: B-06971792054301
Reference: /
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:57

Manufacturer products Authorised representative products Authorised representative actors View details

The Drug Rapid Test (Saliva)

The Drug Rapid Test (Saliva)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792054271
Basic UDI-DI: B-06971792054271
Reference: /
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:57

Manufacturer products Authorised representative products Authorised representative actors View details

Morphine（MOP）Assay Reagent Kit (CMIA)

C2KN011

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052932
Basic UDI-DI: B-06971792052932
Reference: C2KN011
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cocaine（COC）Assay Reagent Kit (CMIA)

C2KN010

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052895
Basic UDI-DI: B-06971792052895
Reference: C2KN010
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

Methylene dioxy methamphetamine (MDMA) Assay Reagent Kit (CMIA)

C2KN009

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052857
Basic UDI-DI: B-06971792052857
Reference: C2KN009
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:56

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorph (BUP) Assay Reagent Kit (CMIA)

C2KN008

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052819
Basic UDI-DI: B-06971792052819
Reference: C2KN008
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:54

Manufacturer products Authorised representative products Authorised representative actors View details

Methcathinone (CATH) Assay Reagent Kit (CMIA)

C2KN007

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052772
Basic UDI-DI: B-06971792052772
Reference: C2KN007
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:54

Manufacturer products Authorised representative products Authorised representative actors View details

Benzodiazepine (BZO) Assay Reagent Kit (CMIA)

C2KN006

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052734
Basic UDI-DI: B-06971792052734
Reference: C2KN006
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:54

Manufacturer products Authorised representative products Authorised representative actors View details

Ketamine (KET) Assay Reagent Kit (CMIA)

C2KN005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052697
Basic UDI-DI: B-06971792052697
Reference: C2KN005
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:54

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine (AMP) Assay Reagent Kit (CMIA)

C2KN004

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052659
Basic UDI-DI: B-06971792052659
Reference: C2KN004
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:54

Manufacturer products Authorised representative products Authorised representative actors View details

Opiates (OPI) Assay Reagent Kit (CMIA)

C2KN003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792052611
Basic UDI-DI: B-06971792052611
Reference: C2KN003
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 13:54

Manufacturer products Authorised representative products Authorised representative actors View details