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221 device results listed.

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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

Ethyl Glucuronide III Enzyme Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008568
Basic UDI-DI: 0850624008EIAEtG30225
Reference: 09976523190
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Ethyl Alcohol (ETOH)

IVDR_67_TTN_DUB-C_B_REAG_ETOH

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596112
Basic UDI-DI: 0405686901708VV
Reference: 11097501
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

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: 00842768023439
Basic UDI-DI: 0405686901107UV
Reference: 10445451
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

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: 00842768023330
Basic UDI-DI: 0405686901227V8
Reference: 10445384
EMDN: W0102090201
EMDN description: ACETAMINOPHENE (PARACETAMOL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Serum Tricyclic Antidepressants Assay

IVDR_67_GLA_DUB-C_B_REAG_Serum TCA Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014314
Basic UDI-DI: 0405686901187VM
Reference: 10445389
EMDN: W0102090215
EMDN description: TRICYCLIC ANTIDEPRESSANTS (TOTAL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Salicylic Acid Assay

IVDR_67_GLA_DUB-C_C_REAG_Salicylic Acid Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001611
Basic UDI-DI: 0405686901302UV
Reference: 10445392
EMDN: W0102090213
EMDN description: SALICYLATE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Salicylate (Sal)

IVDR_67_TTN_DUB-C_C_REAG_SAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414595887
Basic UDI-DI: 0405686900832VQ
Reference: 11097523
EMDN: W0102090213
EMDN description: SALICYLATE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Opium Test Kit (FIA)

VID76

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID763G
Basic UDI-DI: B-VID763G
Reference: VID76-09-011
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Synthetic Marijuana K3 Test Kit (FIA)

VID130

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID130EN
Basic UDI-DI: B-VID130EN
Reference: VID130-09-011
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

ClinMass®

MS8100

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS8100BR
Basic UDI-DI: B-MS8100BR
Reference: MS8100
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

ClinMass®

MS8000

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-MS8000BL
Basic UDI-DI: B-MS8000BL
Reference: MS8000
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 05:16

Manufacturer products View details

One Step Ethyl Glucuronide Test Cassette (Urine)

GBETG-102b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBETG-102bYE
Basic UDI-DI: B-GBETG-102bYE
Reference: GBETG-102b
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ethyl Glucuronide Test Strip (Urine)

GBETG-101b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBETG-101bYB
Basic UDI-DI: B-GBETG-101bYB
Reference: GBETG-101b
EMDN: W0102090220
EMDN description: ETHYL GLUCURONIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

ELISA Ricine eZYDIAG®

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Laboratoire Aguettant
Manufacturer SRN: FR-MF-000000509
UDI-DI: D-FRMF-000000509-RicineUC
Basic UDI-DI: B-FRMF-000000509-RicineUC
Reference: ELISA Ricine eZYDIAG®
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: France
Authorised representative: -
Last updated: 13.07.2026 21:43

Manufacturer products View details

Xylazine (XYL) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DXYL-R102NF
Basic UDI-DI: B-DXYL-R102NF
Reference: DXYL-R102
EMDN: W0102090299
EMDN description: TOXICOLOGY - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 17:18

Manufacturer products Authorised representative products Authorised representative actors View details