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Carbamazepine (CBZ) Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-CBZ-1-AQG
Basic UDI-DI: B-CBZ-1-AQG
Reference: CBZ-1-A
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Aripiprazole (ARP) Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-ARP-2-ASM
Basic UDI-DI: B-ARP-2-ASM
Reference: ARP-2-A
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Aripiprazole (ARP) Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ACtest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000049724
UDI-DI: D-ARP-1-ASG
Basic UDI-DI: B-ARP-1-ASG
Reference: ARP-1-A
EMDN: W0102090199
EMDN description: DRUGS OF ABUSE - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Acetaminophen Assay

IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001550
Basic UDI-DI: 0405686901227V8
Reference: 10445385
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Ethyl alcohol Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_Ethyl alcohol

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022050
Basic UDI-DI: 0405686901106UT
Reference: 10459408
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Acetaminophen Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_ACTM

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005787
Basic UDI-DI: 0405686900208UV
Reference: 10444916
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Emit d.a.u. Amphetamine Class Assay

IVDR_67_GLA_DUB-C_B_KIT_Amphetamine Class Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017148
Basic UDI-DI: 0405686901047V4
Reference: 10445253
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Buprenorphine Assay

IVDR_67_GLA_DUB-C_B_REAG_Buprenorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601106
Basic UDI-DI: 0405686901069VE
Reference: 10720046
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Buprenorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601120
Basic UDI-DI: 0405686901069VE
Reference: 10720048
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Ethyl Alcohol Assay

IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Assay

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002021
Basic UDI-DI: 0405686901107UV
Reference: 10445452
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Cocaine Metabolite Assay

IVDR_67_GLA_DUB-C_B_REAG_Cocaine Metabolite Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001932
Basic UDI-DI: 0405686901088VJ
Reference: 10445437
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Benzodiazepine Assay

IVDR_67_GLA_DUB-C_B_REAG_Benzodiazepine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001895
Basic UDI-DI: 0405686901066V8
Reference: 10445429
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Barbiturate Assay

IVDR_67_GLA_DUB-C_B_REAG_Barbiturate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001871
Basic UDI-DI: 0405686901064V4
Reference: 10445422
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Amphetamines Assay

IVDR_67_GLA_DUB-C_B_REAG_Amphetamines Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001857
Basic UDI-DI: 0405686900202UH
Reference: 10445420
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Buprenorphine Assay

IVDR_67_GLA_DUB-C_B_REAG_Buprenorphine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601113
Basic UDI-DI: 0405686901069VE
Reference: 10720047
EMDN: W0102090117
EMDN description: BUPRENORPHINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Acetaminophen (Acet)

IVDR_67_TTN_DUB-C_C_REAG_ACET

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595894
Basic UDI-DI: 0405686900811VG
Reference: 11097522
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Cocaine Metabolite Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001949
Basic UDI-DI: 0405686901088VJ
Reference: 10445439
EMDN: W0102090106
EMDN description: COCAINE + COCAINE METABOLITES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Benzodiazepine Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001901
Basic UDI-DI: 0405686901066V8
Reference: 10445431
EMDN: W0102090104
EMDN description: BENZODIAZEPINES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Barbiturate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014352
Basic UDI-DI: 0405686901064V4
Reference: 10445423
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Barbiturate Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001888
Basic UDI-DI: 0405686901064V4
Reference: 10445424
EMDN: W0102090103
EMDN description: BARBITURATES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:35

Manufacturer products Authorised representative products Authorised representative actors View details