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32 device results listed.

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Emit II Plus Ecstasy Assay

IVDR_67_GLA_DUB-C_B_REAG_Ecstasy Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002229
Basic UDI-DI: 0405686901098VM
Reference: 10445477
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Ecstasy Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768021947
Basic UDI-DI: 0405686901098VM
Reference: 10445478
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Ecstasy (Xtc)

IVDR_67_TTN_DUB-C_B_REAG_Ecstasy

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595955
Basic UDI-DI: 0405686901700VD
Reference: 11097518
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Emit® II Plus Ecstasy Assay

IVDR_67_GLA_DUB-C_B_REAG_Ecstasy Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768023460
Basic UDI-DI: 0405686901098VM
Reference: 10445479
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

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

Singclean

Panel: 25 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-AMP-05-25tFV
Basic UDI-DI: B-AMP-05-25tFV
Reference: AMP-05-25t
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

Cassette: 25 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-AMP-02-25tEU
Basic UDI-DI: B-AMP-02-25tEU
Reference: AMP-02-25t
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean

Strip: 100 test/box

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: D-AMP-01-100t49
Basic UDI-DI: B-AMP-01-100t49
Reference: AMP-01-100t
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 12.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamines Reagent (AMPH 1 x 250)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-475000PT
Basic UDI-DI: B-475000PT
Reference: 475000
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:05

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Ecstasy (XtcC)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414654201
Basic UDI-DI: 0405686901700VD
Reference: 11701329
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 09.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

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

C2KG009

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753478547
Basic UDI-DI: B-06976753478547
Reference: C2KG009
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Methamphetamine (MAMP) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620957
Basic UDI-DI: B-06974854620957
Reference: P22045
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

Ecstasy (MDMA) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620940
Basic UDI-DI: B-06974854620940
Reference: P22044
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine (AMP) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620889
Basic UDI-DI: B-06974854620889
Reference: P22038
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine (AMP) Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303681
Basic UDI-DI: B-06974566303681
Reference: DAM-105
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Methamphetamine (MET) Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303087
Basic UDI-DI: B-06974566303087
Reference: DME-105
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Hair Methamphetamine (MET) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521005650
Basic UDI-DI: B-06974521005650
Reference: SUPF058025
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

MET Rapid Test Kit (Colloidal gold method)

DP005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473301626
Basic UDI-DI: B-06974473301626
Reference: DP005
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

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

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