Public EUDAMED Search

EUDAMED Device Search

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

Last updated

05.07.2026 13:36

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Active filter:Manufacturer SRN:US-MF-000023925

101 device results listed.

Page 1 / 6

ARK Lacosamide Control

5033-0003-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003353
Basic UDI-DI: B-00858724003353
Reference: 5033-0003-00
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Lacosamide Calibrator

5033-0002-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003346
Basic UDI-DI: B-00858724003346
Reference: 5033-0002-00
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Lacosamide Assay

5033-0001-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003339
Basic UDI-DI: B-00858724003339
Reference: 5033-0001-00
EMDN: W0102080299
EMDN description: CENTRAL NERVOUS SYSTEM TDM - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Voriconazole II Control

5030-0003-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003247
Basic UDI-DI: B-00858724003247
Reference: 5030-0003-01
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Voriconazole II Calibrator

5030-0002-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003230
Basic UDI-DI: B-00858724003230
Reference: 5030-0002-01
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Voriconazole II Assay

5030-0001-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003223
Basic UDI-DI: B-00858724003223
Reference: 5030-0001-01
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Topiramate Control

5015-0003-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003124
Basic UDI-DI: B-00858724003124
Reference: 5015-0003-00
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Topiramate Calibrator

5015-0002-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003063
Basic UDI-DI: B-00858724003063
Reference: 5015-0002-00
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Topiramate Assay

5015-0001-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003001
Basic UDI-DI: B-00858724003001
Reference: 5015-0001-00
EMDN: W0102080213
EMDN description: TOPIRAMATE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Control

5039-0003-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030172
Basic UDI-DI: B-00812101030172
Reference: 5039-0003-00
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Calibrator

5039-0002-02

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030165
Basic UDI-DI: B-00812101030165
Reference: 5039-0002-02
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Calibrator

5039-0002-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030158
Basic UDI-DI: B-00812101030158
Reference: 5039-0002-01
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Calibrator

5039-0002-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030141
Basic UDI-DI: B-00812101030141
Reference: 5039-0002-00
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Assay

5039-0001-01

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030134
Basic UDI-DI: B-00812101030134
Reference: 5039-0001-01
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Meperidine Assay

5039-0001-00

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101030127
Basic UDI-DI: B-00812101030127
Reference: 5039-0001-00
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Methotrexate Dilution Buffer

-

IVD Class ANot specifiedOn the market

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003209
Basic UDI-DI: 0858724003MTX026AJ7
Reference: 5026-0004-00
EMDN: -
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.06.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Fentanyl Control

-

IVD Class BNot specifiedOn the market

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003421
Basic UDI-DI: 0858724003FEN069Y8
Reference: 5031-0003-00
EMDN: -
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.06.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Fentanyl Calibrator

-

IVD Class BNot specifiedOn the market

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003445
Basic UDI-DI: 0858724003FEN069Y8
Reference: 5031-0002-01
EMDN: -
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.06.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Fentanyl Calibrator

-

IVD Class BNot specifiedOn the market

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003452
Basic UDI-DI: 0858724003FEN069Y8
Reference: 5031-0002-02
EMDN: -
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.06.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ethyl Glucuronide Assay

-

IVD Class BNot specifiedOn the market

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003469
Basic UDI-DI: 0858724003ETG03633
Reference: 5036-0001-00
EMDN: -
EMDN description: ETHYL GLUCURONIDE
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.06.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details