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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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ARK Ketamine II Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031636
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0002-01
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine II Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031643
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0002-02
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine II Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031650
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0002-03
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine II Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031667
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0003-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine II Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031674
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0003-01
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ketamine II Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031995
Basic UDI-DI: 0858724003KET0833G
Reference: 5083-0001-03
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

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: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ethyl Glucuronide II Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101032091
Basic UDI-DI: 0858724003ETG0773H
Reference: 5077-0001-01
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ethyl Glucuronide II Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101032107
Basic UDI-DI: 0858724003ETG0773H
Reference: 5077-0001-02
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ethyl Glucuronide II Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101032114
Basic UDI-DI: 0858724003ETG0773H
Reference: 5077-0001-03
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Pregabalin II Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101032169
Basic UDI-DI: 0858724003PGB0592C
Reference: 5059-0001-02
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK HS Benzodiazepine II Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101032183
Basic UDI-DI: 0858724003BZD0733F
Reference: 5073-0001-03
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

CLO Rapid Test Cassette