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859 device results listed.

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Dimension LOCI Thyroid Calibrator

IVDR_67_GLA_DUB-C_B_REAG_LOCI THYR CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768031694
Basic UDI-DI: 0405686901140UT
Reference: 10484354
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Ferritin Calibrator

IVDR_67_GLA_DUB-C_B_REAG_FERR CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013744
Basic UDI-DI: 0405686901112UN
Reference: 10445017
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Ethyl Alcohol 100 mg/dL Calibrator

IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol Cals and Controls

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001994
Basic UDI-DI: 0405686901108UX
Reference: 10445448
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: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Calibrator B Level 2 (high)

IVDR_67_GLA_DUB-C_B_REAG_Cal B Lev 1 (cutoff) Lev 2 (high)

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001802
Basic UDI-DI: 0405686901071UZ
Reference: 10445413
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: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Emit Calibrator Level 0 (negative)

IVDR_67_GLA_DUB-C_B_REAG_Calibrator Level 0 (negative)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001703
Basic UDI-DI: 0405686901073V5
Reference: 10445403
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: 23.07.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Clonatest

ASLO-Turbidimetric Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873300223
Basic UDI-DI: B-84352873300223
Reference: CT39101
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 22.07.2026 22:54

Manufacturer products View details

Clonatest

ASLO-Turbidimetric Calibrator Set

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873300216
Basic UDI-DI: B-84352873300216
Reference: CT39100
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 22.07.2026 22:54

Manufacturer products View details

Cromatest

ASLO-Turbidimetric Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873300209
Basic UDI-DI: B-84352873300209
Reference: 3931120
EMDN: W0102152210
EMDN description: STANDARDS AND CALIBRATORS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: -
Last updated: 22.07.2026 22:54

Manufacturer products View details

Dimension LOCI Anemia Calibrator

IVDR_67_GLA_DUB-C_B_REAG_LOCI Anemia CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414976631
Basic UDI-DI: 0405686901139VA
Reference: 10463372
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Cytokeratin Fragment Calibrator 21-1 (CYFRA CAL)

IVDR_67_TTN_DUB-C_C_REAG_CYFRA CAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414622804
Basic UDI-DI: 0405686902360VJ
Reference: 11553957
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM)

IVDR_67_TTN_DUB-C_B_REAG_aTPOII MCM

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414608822
Basic UDI-DI: 0405686902271VJ
Reference: 11203693
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Drug Calibrator / Control Level 3

IVDR_67_GLA_DUB-C_B_REAG_Specialty Drug Cals/Ctls Levels 1-4

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601151
Basic UDI-DI: 0405686901190VA
Reference: 10720051
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: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

ARCHITECT

ARCHITECT NSE

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175627
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 22.07.2026 00:44

Manufacturer products View details

ARCHITECT

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175634
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3210
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:53

Manufacturer products View details

Emit tox Acetaminophen Calibrators

IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen Calibrators

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768001567
Basic UDI-DI: 0405686901228VA
Reference: 10445386
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: 21.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator D (CAL D)

IVDR_67_TTN_DUB-C_C_REAG_CAL D

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598369
Basic UDI-DI: 0405686901831VV
Reference: 10995509
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator 30 (CAL 30)

IVDR_67_TTN_DUB-C_C_REAG_Calibrator 30

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598239
Basic UDI-DI: 0405686901835W5
Reference: 10995496
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator 30

IVDR_67_TTN_DUB-C_C_REAG_Calibrator 30

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414578491
Basic UDI-DI: 0405686901835W5
Reference: 10379811
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
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

ADVIA Centaur Calibrator D (CAL D)

IVDR_67_TTN_DUB-C_C_REAG_CAL D

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414124933
Basic UDI-DI: 0405686901831VV
Reference: 10311576
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 23:03

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus 6-AM/Ecstasy Calibrator/Control Level 2

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: 00842768034145
Basic UDI-DI: 0405686901053UX
Reference: 10470442
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: 20.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details