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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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01.08.2026 09:11

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52 device results listed.

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16438153817243

DoA Calibrator B1

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817243
Basic UDI-DI: B-16438153817243
Reference: 981724
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817229

DoA Calibrator A2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817229
Basic UDI-DI: B-16438153817229
Reference: 981722
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817212

DoA Calibrator A 1

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817212
Basic UDI-DI: B-16438153817212
Reference: 981721
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817205

DoA Negative Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817205
Basic UDI-DI: B-16438153817205
Reference: 981720
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

Fentanyl Control Set

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008636
Basic UDI-DI: 0850624008CCFEN2024V
Reference: 10426667190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 09.07.2026 00:37

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

Urine MultiDoA Calibrators

0018166100

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426951296620
Basic UDI-DI: 84269512966209N
Reference: 0018166100
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 13:14

Manufacturer products View details

Urine MutiDoA Negative Calibrator

0018166000

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426951296613
Basic UDI-DI: 84269512966139R
Reference: 0018166000
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 13:14

Manufacturer products View details

Urine DoA Oxycodone Calibrators

DRI Oxycodone

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

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08059307640350
Basic UDI-DI: 80593076403675H
Reference: 0018169200
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:24

Manufacturer products View details

DRI Oxycodone

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

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08059307640367
Basic UDI-DI: 80593076403675H
Reference: 0018169540
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 06:09

Manufacturer products View details