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59 device results listed.

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Atellica IM Cyclosporine Calibrator (CsA CAL)

IVDR_67_TTN_DUB-C_C_REAG_CsA Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598734
Basic UDI-DI: 0405686901841VY
Reference: 10995549
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH DRUG CAL II (DRUG CAL II)

IVDR_67_TTN_DUB-C_C_REAG_DRUG CAL II

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597485
Basic UDI-DI: 0405686901850VZ
Reference: 11099405
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Cyclosporine Specific Negative Calibrator

IVDR_67_GLA_DUB-C_C_REAG_Cyclosporine Specific Calibrators

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001475
Basic UDI-DI: 0405686901250V3
Reference: 10445377
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Cyclosporine Specific Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Cyclosporine Specific Calibrators

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001468
Basic UDI-DI: 0405686901250V3
Reference: 10445376
EMDN: W0102152201
EMDN description: TDM/DRUG 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

Emit Antiepileptic Drug Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Antiepileptic Drug Calibrators

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001253
Basic UDI-DI: 0405686901061UW
Reference: 10445353
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Gentamicin Plus Calibrators

IVDR_67_GLA_DUB-C_B_REAG_Gentamicin Plus Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001093
Basic UDI-DI: 0405686901119V4
Reference: 10445334
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Digoxin Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Digoxin Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000973
Basic UDI-DI: 0405686901255VD
Reference: 10445316
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Carbamazepine Calibrators

IVDR_67_GLA_DUB-C_B_REAG_Carbamazepine Calibrators

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768000935
Basic UDI-DI: 0405686901076VB
Reference: 10445310
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Methotrexate Dilution Buffer

5026-0004-00

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testing

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003209
Basic UDI-DI: 0858724003MTX026AJ7
Reference: 5026-0004-00
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Methotrexate II Dilution Buffer

5071-0004-00

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testing

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031223
Basic UDI-DI: 0858724003MTX071AJH
Reference: Reference Number
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

N aTNFa Standard ADA

IVDR_27_MAR EB_B_N_aTNFa_Cal_ADA_ETA_INF

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615394
Basic UDI-DI: 0405686902179VV
Reference: 10873739
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details

Atellica CH DRUG CAL (DRUG CAL)

IVDR_67_TTN_DUB-C_B_REAG_DRUG CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597386
Basic UDI-DI: 0405686901697WH
Reference: 11099336
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 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Sirolimus Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Sirolimus Calibrators

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768029622
Basic UDI-DI: 0405686901309VB
Reference: 10445402
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 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Sirolimus Calibrator

IVDR_67_GLA_DUB-C_C_REAG_SIRO CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768022128
Basic UDI-DI: 0405686901306V5
Reference: 10464327
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 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Emit 2000 Phenytoin Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Phenytoin Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017391
Basic UDI-DI: 0405686901162V5
Reference: 10445304
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 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® DRUG Calibrator

IVDR_67_GLA_DUB-C_C_REAG_DRUG CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005022
Basic UDI-DI: 0405686901260V6
Reference: 10445014
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 Tacrolimus Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Tacrolimus Calibrators

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001680
Basic UDI-DI: 0405686901311UW
Reference: 10445399
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 tox Salicylic Acid Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Salicylic Acid Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001628
Basic UDI-DI: 0405686901303UX
Reference: 10445393
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 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