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61 device results listed.

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Emit 2000 Vancomycin Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Vancomycin Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001116
Basic UDI-DI: 0405686901222UW
Reference: 10445337
EMDN: W0102152201
EMDN description: TDM/DRUG 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 2000 Tobramycin Calibrators

IVDR_67_GLA_DUB-C_B_REAG_Tobramycin Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001079
Basic UDI-DI: 0405686901204UU
Reference: 10445331
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Quinidine Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Quinidine Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001055
Basic UDI-DI: 0405686901299VZ
Reference: 10445328
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Theophylline Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Theophylline Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001031
Basic UDI-DI: 0405686901197VQ
Reference: 10445325
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 N-Acetylprocainamide Calibrators

IVDR_67_GLA_DUB-C_C_REAG_N-Acetylprocainamide Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001017
Basic UDI-DI: 0405686901288VU
Reference: 10445322
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Procainamide Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Procainamide Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000997
Basic UDI-DI: 0405686901294VP
Reference: 10445319
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Valproic Acid Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Valproic Acid Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000959
Basic UDI-DI: 0405686901219V9
Reference: 10445313
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Calibrators

IVDR_67_LLB_DUB-C_C_REAG_Mycophenolic Acid_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414168272
Basic UDI-DI: 0405686900732VK
Reference: 10730959
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Tacrolimus Calibrator

IVDR_67_GLA_DUB-C_C_REAG_TAC_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768035432
Basic UDI-DI: 0405686900215US
Reference: 10700796
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
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

Emit 2000 Mycophenolic Acid Controls

IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid controls

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001512
Basic UDI-DI: 0405686900213UN
Reference: 10445381
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Mycophenolic Acid Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Mycophenolic Acid calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001505
Basic UDI-DI: 0405686900212UL
Reference: 10445380
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

ARCHITECT

ARCHITECT iPhenytoin

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740001797
Basic UDI-DI: 038074ARP0134NY
Reference: 01P3401
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 15.07.2026 23:23

Manufacturer products View details

ARCHITECT

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740001803
Basic UDI-DI: 038074ARP0134NY
Reference: 01P3425
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 23:01

Manufacturer products View details

SYNCHRON Systems DAT Multi-Drug Low Urine Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474970RN
Basic UDI-DI: B-474970RN
Reference: 474970
EMDN: W0102152201
EMDN description: TDM/DRUG 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 Drug Calibrator 3 Plus

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-471080PP
Basic UDI-DI: B-471080PP
Reference: 471080
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Drug Calibrator 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469630RK
Basic UDI-DI: B-469630RK
Reference: 469630
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems Drug Calibrator 1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469600RA
Basic UDI-DI: B-469600RA
Reference: 469600
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Antimycotic Medication Reagent Set

4280 P AMM

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4280PAMMMR
Basic UDI-DI: B-4280PAMMMR
Reference: 4280 P AMM
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:44

Manufacturer products View details

Benzodiazepines Reagent Set

4240 P BZD

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4240PBZDLX
Basic UDI-DI: B-4240PBZDLX
Reference: 4240 P BZD
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:16

Manufacturer products View details

Nortriptyline Reagent Set

4140 P NTP

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: D-4140PNTPNG
Basic UDI-DI: B-4140PNTPNG
Reference: 4140 P NTP
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:08

Manufacturer products View details