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436 device results listed.

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D-697994388Ir0643NEB

MAMP Methamphetamine Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0643NEB
Basic UDI-DI: B-697994388Ir0643NEB
Reference: Ir064
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0633LE2

MOR Morphine Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0633LE2
Basic UDI-DI: B-697994388Ir0633LE2
Reference: Ir063
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:25

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Test Dip Card

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308372
Basic UDI-DI: B-69743840308372
Reference: 3034401
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

ARK EDDP Assay

5051-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003841
Basic UDI-DI: 0858724003EDDP0515Z
Reference: 5051-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Tramadol Assay

5040-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003773
Basic UDI-DI: 0858724003TRA0406V
Reference: 5040-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Methylphenidate Metabolite Assay

5042-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003544
Basic UDI-DI: 0858724003MHP0423Z
Reference: 5042-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ethyl Glucuronide II Assay

5077-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101032084
Basic UDI-DI: 0858724003ETG0773H
Reference: 5077-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine II Assay

5083-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031599
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Zopiclone Assay

5043-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031308
Basic UDI-DI: 0858724003ZPC04399
Reference: 5043-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Fentanyl II Assay

5069-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030561
Basic UDI-DI: 0858724003FEN069Y8
Reference: 5069-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Pregabalin II Assay

5059-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030448
Basic UDI-DI: 0858724003PGB0592C
Reference: 5059-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine Assay

5056-0001-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030004
Basic UDI-DI: 0858724003KET0563D
Reference: 5056-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

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

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

VivaDiag™ MDPHP Rapid Test

VDMDP-A102

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VDMDP-A102G3
Basic UDI-DI: B-VDMDP-A102G3
Reference: VDMDP-A102
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