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216 device results listed.

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ACE Rapid Test Panel

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DAC-114GB
Basic UDI-DI: B-DAC-114GB
Reference: DAC-114
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

ACE Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DAC-102G4
Basic UDI-DI: B-DAC-102G4
Reference: DAC-102
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

ACE Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DAC-101G2
Basic UDI-DI: B-DAC-101G2
Reference: DAC-101
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.08.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Saliva Alcohol Test Strip

1L29S5

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963710598
Basic UDI-DI: B-06921963710598
Reference: 1L29S5
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:55

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Rapid Urine Alcohol Test Card

1L29C3

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963710567
Basic UDI-DI: B-06921963710567
Reference: 1L29C3
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:55

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Alcohol Rapid Test Panel

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DAL-114KE
Basic UDI-DI: B-DAL-114KE
Reference: DAL-114
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:30

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Alcohol Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DAL-102K7
Basic UDI-DI: B-DAL-102K7
Reference: DAL-102
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:30

Manufacturer products Authorised representative products Authorised representative actors View details

Alcohol Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DAL-101K5
Basic UDI-DI: B-DAL-101K5
Reference: DAL-101
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Belgium
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:30

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"Etomidate (ETO) Rapid Test Midstream -Saliva"

Etomidate (ETO) Rapid Test Midstream -Saliva

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: D-D-DOA73M25S7Y
Basic UDI-DI: B-D-DOA73M25S7Y
Reference: D-DOA73M25S
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 02:30

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Etomidate (ETO) Rapid Test Device-Saliva

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: D-D-DOA73D20S5J
Basic UDI-DI: B-D-DOA73D20S5J
Reference: D-DOA73D20S
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 02:30

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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

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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 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

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 Ethyl Alcohol Assay

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014413
Basic UDI-DI: 0405686901107UV
Reference: 10445446
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
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 Ethyl Alcohol Assay

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002038
Basic UDI-DI: 0405686901107UV
Reference: 10445453
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
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

Urine Alcohol Test Strip

GBALC-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBALC-101aOGJY
Basic UDI-DI: B-GBALC-101aOGJY
Reference: GBALC-101a
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

50604284400430

K9001

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Cambridge Life Sciences Ltd
Manufacturer SRN: GB-MF-000026451
UDI-DI: 50604284400430
Basic UDI-DI: B-50604284400430
Reference: K9001
EMDN: W0102090213
EMDN description: SALICYLATE
First on market country: Germany
Authorised representative: Glenbio Ireland Ltd.
Last updated: 17.07.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Ethyl Glucuronide Assay

5036-0001-00

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

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003469
Basic UDI-DI: 0858724003ETG03633
Reference: 5036-0001-00
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:43

Manufacturer products Authorised representative products Authorised representative actors View details