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Emit II Plus Oxycodone Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414027937
Basic UDI-DI: 0405686901153V4
Reference: 10720816
EMDN: W0102090123
EMDN description: OXYCODINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:47

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 Assay

5036-0001-00

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003469
Basic UDI-DI: 0858724003ETG03633
Reference: 5036-0001-00
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
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 HS Benzodiazepine II Assay

5073-0001-00

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030479
Basic UDI-DI: 0858724003BZD0733F
Reference: 5073-0001-00
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
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 AB-PINACA Assay

5055-0001-00

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030349
Basic UDI-DI: 0858724003ABP055V9
Reference: 5055-0001-00
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 UR-144/JWH-018 Assay

5054-0001-00

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030240
Basic UDI-DI: 0858724003URJ0549L
Reference: 5054-0001-00
EMDN: W0102090105
EMDN description: CANNABINOIDS
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

Fentanyl II Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008643
Basic UDI-DI: 0850624008EIAFEN202MD
Reference: 10427531190
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Ethyl Glucuronide III Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008568
Basic UDI-DI: 0850624008EIAEtG30225
Reference: 09976523190
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008018
Basic UDI-DI: 0850624008EIABUP02C9
Reference: 08362955190
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

6-Acetylmorphine Enzyme Immunoassay

08240035190

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008001
Basic UDI-DI: 0850624008EIA6AM023M
Reference: 08240035190
EMDN: W0102090116
EMDN description: 6-ACETHYLMORPHIUM
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Ethyl Alcohol (ETOH)

IVDR_67_TTN_DUB-C_B_REAG_ETOH

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596112
Basic UDI-DI: 0405686901708VV
Reference: 11097501
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Opiates (Op)

IVDR_67_TTN_DUB-C_B_REAG_OP_2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596105
Basic UDI-DI: 0405686901753W2
Reference: 11097502
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details