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26 device results listed.

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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 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 Amphetamines Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014345
Basic UDI-DI: 0405686900202UH
Reference: 10445418
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
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

Dimension Urine Amphetamine/Methamphetamine Screen Flex reagent cartridge

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005817
Basic UDI-DI: 0405686900202UH
Reference: 10444926
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
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 Amphetamines Assay

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001864
Basic UDI-DI: 0405686900202UH
Reference: 10445421
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
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

Atellica CH Amphetamines (Amp)

IVDR_67_TTN_DUB-C_B_REAG_Amp

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414596068
Basic UDI-DI: 0405686900766W4
Reference: 11097506
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
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

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: 00842768023361
Basic UDI-DI: 0405686900202UH
Reference: 10445419
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

CAF Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-DCAF-R102SP
Basic UDI-DI: B-DCAF-R102SP
Reference: DCAF-R102
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors 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

Atellica CH Amphetamine (AmpC)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414654171
Basic UDI-DI: 0405686900766W4
Reference: 11701324
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 09.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine (AMP) Assay Reagent Kit (CMIA)

C2KG004

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753478332
Basic UDI-DI: B-06976753478332
Reference: C2KG004
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Hair 3,4-Methylenedioxymethamphetamine (MDMA) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521005612
Basic UDI-DI: B-06974521005612
Reference: SUPF061025
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

AMP Rapid Test Kit (Colloidal gold method)

DP001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473304207
Basic UDI-DI: B-06974473304207
Reference: DP001
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

Amphetamine (AMP) Rapid Test (Urine)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910520
Basic UDI-DI: B-06974238910520
Reference: NAMP044
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

00884883012523

10016417

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883012523
Basic UDI-DI: B-00884883012523
Reference: 10016417
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

00884883011069

10014947

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883011069
Basic UDI-DI: B-00884883011069
Reference: 10014947
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:29

Manufacturer products Authorised representative products Authorised representative actors View details

00884883004665

10014585

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883004665
Basic UDI-DI: B-00884883004665
Reference: 10014585
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:20

Manufacturer products Authorised representative products Authorised representative actors View details

00884883004085

100040

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883004085
Basic UDI-DI: B-00884883004085
Reference: 100040
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:19

Manufacturer products Authorised representative products Authorised representative actors View details

00884883002821

0018

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883002821
Basic UDI-DI: B-00884883002821
Reference: 0018
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details

00884883002524

0017

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883002524
Basic UDI-DI: B-00884883002524
Reference: 0017
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:15

Manufacturer products Authorised representative products Authorised representative actors View details