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Emit II Plus Cannabinoid Assay

IVDR_67_GLA_DUB-C_B_REAG_Cannabinoid Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002182
Basic UDI-DI: 0405686901075V9
Reference: 10445469
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Phencyclidine Assay

IVDR_67_GLA_DUB-C_B_REAG_Phencyclidine Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001956
Basic UDI-DI: 0405686901158VE
Reference: 10445441
EMDN: W0102090114
EMDN description: PHENCYCLIDINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Propoxyphene Assay

IVDR_67_GLA_DUB-C_B_REAG_Propoxyphene Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001918
Basic UDI-DI: 0405686901169VK
Reference: 10445433
EMDN: W0102090115
EMDN description: PROPOXYPHENE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Opiate Assay

IVDR_67_GLA_DUB-C_B_REAG_Opiate Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001819
Basic UDI-DI: 0405686901152V2
Reference: 10445416
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Serum Barbiturate Assay

IVDR_67_GLA_DUB-C_B_KIT_Barbiturate Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001604
Basic UDI-DI: 0405686901048V6
Reference: 10445391
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Serum Benzodiazepine Assay

IVDR_67_GLA_DUB-C_B_KIT_Benzodiazepine Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001581
Basic UDI-DI: 0405686901049V8
Reference: 10445388
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Methadone Assay

IVDR_67_GLA_DUB-C_B_REAG_Methadone Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000133
Basic UDI-DI: 0405686901148VB
Reference: 10445426
EMDN: W0102090110
EMDN description: METHADONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus 6-Acetylmorphine Assay

IVDR_67_GLA_DUB-C_B_REAG_6-Acetylmorphine Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414229591
Basic UDI-DI: 0405686901052UV
Reference: 10730975
EMDN: W0102090116
EMDN description: 6-ACETHYLMORPHIUM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Oxycodone Assay

IVDR_67_GLA_DUB-C_B_REAG_Oxycodone Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414028019
Basic UDI-DI: 0405686901153V4
Reference: 10720808
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Amphetamines (Amp)

IVDR_67_TTN_DUB-C_B_REAG_Amp

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596068
Basic UDI-DI: 0405686900766W4
Reference: 11097506
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Amphetamines Assay

IVDR_67_GLA_DUB-C_B_REAG_Amphetamines Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023361
Basic UDI-DI: 0405686900202UH
Reference: 10445419
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Drug of Abuse Combo (MOP/MET/KET) Test Kit (FIA)

VID46

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID4637
Basic UDI-DI: B-VID4637
Reference: VID46-09-011
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Tetrahydrocannabinol Test Kit (FIA)

VID40

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID402T
Basic UDI-DI: B-VID402T
Reference: VID40-09-011
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Ketamine Test Kit (FIA)

VID39

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID393A
Basic UDI-DI: B-VID393A
Reference: VID39-09-011
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Methamphetamine Test Kit (FIA)

VID38

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID3838
Basic UDI-DI: B-VID3838
Reference: VID38-09-011
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Morphine Test Kit (FIA)

VID37

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID3736
Basic UDI-DI: B-VID3736
Reference: VID37-09-011
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:22

Manufacturer products Authorised representative products Authorised representative actors View details

Meprobamate (MEB) Rapid Test

VDMEB-104

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMEB-104DE
Basic UDI-DI: B-VDMEB-104DE
Reference: VDMEB-104
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
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

Meprobamate (MEB) Rapid Test

VDMEB-102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMEB-102DA
Basic UDI-DI: B-VDMEB-102DA
Reference: VDMEB-102
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
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

VivaDiag™ MDPHP Rapid Test

VDMDP-A104

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMDP-A104G7
Basic UDI-DI: B-VDMDP-A104G7
Reference: VDMDP-A104
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
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

Meprobamate (MEB) Rapid Test

VDMEB-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMEB-101D8
Basic UDI-DI: B-VDMEB-101D8
Reference: VDMEB-101
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
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