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EUDAMED Device Search

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Amphetamines Reagent (AMPH 1 x 250)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-475000PT
Basic UDI-DI: B-475000PT
Reference: 475000
EMDN: W0102090102
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:05

Manufacturer products Authorised representative products Authorised representative actors View details

Cannabinoid 100 ng Reagent (THC 1 x 150)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445990R2
Basic UDI-DI: B-445990R2
Reference: 445990
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

Cannabinoid 20 ng Reagent (THC2 1 x 150)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445824QG
Basic UDI-DI: B-445824QG
Reference: 445824
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

TheraCHECK Dip Drug Test

30523-FRA

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSingle use

Manufacturer: CareHealth America Corporation
Manufacturer SRN: US-MF-000025798
UDI-DI: D-30523-FRAQ5
Basic UDI-DI: B-30523-FRAQ5
Reference: 30523-FRA
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 11.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

TheraCHECK Dip Drug Test

30170C-FRA

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSingle use

Manufacturer: CareHealth America Corporation
Manufacturer SRN: US-MF-000025798
UDI-DI: D-30170C-FRAAK
Basic UDI-DI: B-30170C-FRAAK
Reference: 30170C-FRA
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: France
Authorised representative: AR Experts B.V.
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

16438153817373

DoA Control set E

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817373
Basic UDI-DI: B-16438153817373
Reference: 981737
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:46

Manufacturer products View details

16438153817335

DoA Control set C

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817335
Basic UDI-DI: B-16438153817335
Reference: 981733
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:46

Manufacturer products View details

16438153817281

DoA Control set B

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817281
Basic UDI-DI: B-16438153817281
Reference: 981728
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817236

DoA Control set A

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817236
Basic UDI-DI: B-16438153817236
Reference: 981723
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

METHADONE

Methadone

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816833
Basic UDI-DI: B-16438153816833
Reference: 981683
EMDN: W0102090110
EMDN description: METHADONE
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

OPIATES

Opiates

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816253
Basic UDI-DI: B-16438153816253
Reference: 981625
EMDN: W0102090113
EMDN description: OPIATES
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

COCAINE METABOLITE

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816246
Basic UDI-DI: B-16438153816246
Reference: 981624
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

CANNABINOIDS

Cannabinoids

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816239
Basic UDI-DI: B-16438153816239
Reference: 981623
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

BENZODIAZEPINES

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816222
Basic UDI-DI: B-16438153816222
Reference: 981622
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153816215

Barbiturates

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816215
Basic UDI-DI: B-16438153816215
Reference: 981621
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153816208

Amphetamines

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153816208
Basic UDI-DI: B-16438153816208
Reference: 981620
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

Emit II Plus Cannabinoid Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002199
Basic UDI-DI: 0405686901075V9
Reference: 10445471
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Cannabinoid Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014420
Basic UDI-DI: 0405686901075V9
Reference: 10445470
EMDN: W0102090105
EMDN description: CANNABINOIDS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

R-test Multi-5 Drug Panel Rapid Test

R-41025

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Lab Diagnostic Systems (SMC) Pvt. Ltd.
Manufacturer SRN: PK-MF-000046055
UDI-DI: 08964004385018
Basic UDI-DI: B-08964004385018
Reference: R-41025
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 10.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

GenBody KET

DKET010

IVD generalIVDDNo longer on the marketKitProfessional testingReagentSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700918
Basic UDI-DI: B-08800076700918
Reference: DKET010
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details