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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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23.09.2026 04:15

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ARK Ketamine Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030011
Basic UDI-DI: 0858724003KET0563D
Reference: 5056-0001-01
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 Ketamine Calibrator

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030028
Basic UDI-DI: 0858724003KET0563D
Reference: 5056-0002-00
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 Calibrator

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030035
Basic UDI-DI: 0858724003KET0563D
Reference: 5056-0002-01
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 Calibrator

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030042
Basic UDI-DI: 0858724003KET0563D
Reference: 5056-0002-02
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 Control

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030059
Basic UDI-DI: 0858724003KET0563D
Reference: 5056-0003-00
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 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: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK UR-144/JWH-018 Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030257
Basic UDI-DI: 0858724003URJ0549L
Reference: 5054-0001-01
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 UR-144/JWH-018 Calibrator

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030264
Basic UDI-DI: 0858724003URJ0549L
Reference: 5054-0002-01
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 UR-144/JWH-018 Calibrator

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030271
Basic UDI-DI: 0858724003URJ0549L
Reference: 5054-0002-02
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 UR-144/JWH-018 Control

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030288
Basic UDI-DI: 0858724003URJ0549L
Reference: 5054-0003-00
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 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: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK AB-PINACA Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030356
Basic UDI-DI: 0858724003ABP055V9
Reference: 5055-0001-01
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 AB-PINACA Calibrator

-

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030363
Basic UDI-DI: 0858724003ABP055V9
Reference: 5055-0002-01
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 AB-PINACA Calibrator

-

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030370
Basic UDI-DI: 0858724003ABP055V9
Reference: 5055-0002-02
EMDN: W0102090105
EMDN description: CANNABINOIDS
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 AB-PINACA Control

-

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030387
Basic UDI-DI: 0858724003ABP055V9
Reference: 5055-0003-00
EMDN: W0102090105
EMDN description: CANNABINOIDS
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

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: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Pregabalin II Calibrator

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030455
Basic UDI-DI: 0858724003PGB0592C
Reference: 5059-0002-00
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 Pregabalin II Control

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030462
Basic UDI-DI: 0858724003PGB0592C
Reference: 5059-0003-00
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 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: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

ARK HS Benzodiazepine II Assay

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030486
Basic UDI-DI: 0858724003BZD0733F
Reference: 5073-0001-01
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