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52 device results listed.

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Emit Calibrator/Control Level 1

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001741
Basic UDI-DI: 0405686901074V7
Reference: 10445407
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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 6-AM/Ecstasy Calibrator/Control Level 1

IVDR_67_GLA_DUB-C_B_REAG_6-AM/Ecstasy Cals/Ctls Levels 1-4

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768034138
Basic UDI-DI: 0405686901053UX
Reference: 10470441
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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

Lysun

DOAD-U112

IVD generalIVDDNo longer on the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 6971771202235
Basic UDI-DI: B-6971771202235
Reference: RPS/15/2024
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 04:00

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine 5 Qualitative Calibrator Set

Buprenorphine Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008070
Basic UDI-DI: 0850624008CCBUP02Y8
Reference: 08356661190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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

Fentanyl Qualitative Calibrator Set

Fentanyl Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008278
Basic UDI-DI: 0850624008CCFEN2024V
Reference: 09330097190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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

6-Acetylmorphine Semi-Quantitative Calibrators Set

6-Acetylmorphine Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008056
Basic UDI-DI: 0850624008CC6AM02PL
Reference: 08240183190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Emit tox Serum Tricyclic Antidepressants Calibrator/Controls

IVDR_67_GLA_DUB-C_B_REAG_Serum TCA Calibrator/Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768014321
Basic UDI-DI: 0405686901188VP
Reference: 10445390
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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 LSD 1.5 ng/mL Calibrator

IVDR_67_GLA_DUB-C_B_REAG_LSD Calibrators

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768002076
Basic UDI-DI: 0405686901142UX
Reference: 10445457
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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

Emit Calibrator/Control Level 2

IVDR_67_GLA_DUB-C_B_REAG_Calibrator/Control

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001758
Basic UDI-DI: 0405686901074V7
Reference: 10445408
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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

Emit tox Serum Calibrators

IVDR_67_GLA_DUB-C_B_REAG_Serum Calibrators

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001574
Basic UDI-DI: 0405686901186VK
Reference: 10445387
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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

LZI Methadone Metabolite (EDDP) 100 Low Calibrator (50 ng/mL)

Methadone Metabolite Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: B0760202B0
Basic UDI-DI: ++B076CCEDDP01HT
Reference: 0202b
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 15.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems OP 300 Low Urine Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474982RV
Basic UDI-DI: B-474982RV
Reference: 474982
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 100 ng/mL THC Urine Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-445811Q7
Basic UDI-DI: B-445811Q7
Reference: 445811
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
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

16438153817366

DoA Calibration set E

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817366
Basic UDI-DI: B-16438153817366
Reference: 981736
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:46

Manufacturer products View details

16438153817311

DoA Calibrator C3

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817311
Basic UDI-DI: B-16438153817311
Reference: 981731
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:46

Manufacturer products View details

16438153817304

DoA Calibrator C2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817304
Basic UDI-DI: B-16438153817304
Reference: 981730
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817298

DoA Calibrator C1

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817298
Basic UDI-DI: B-16438153817298
Reference: 981729
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817274

DoA Calibrator B4

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817274
Basic UDI-DI: B-16438153817274
Reference: 981727
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817267

DoA Calibrator B3

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817267
Basic UDI-DI: B-16438153817267
Reference: 981726
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details

16438153817250

DoA Calibrator B2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153817250
Basic UDI-DI: B-16438153817250
Reference: 981725
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 08:45

Manufacturer products View details