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85 device results listed.

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Atellica IM HER-2/neu Calibrator (H2n CAL)

IVDR_67_TTN_DUB-C_C_REAG_H2n Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599168
Basic UDI-DI: 0405686901853W7
Reference: 10995592
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BR 27.29 Calibrator (BR CAL)

IVDR_67_TTN_DUB-C_C_REAG_BR CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598420
Basic UDI-DI: 0405686901826W4
Reference: 10995515
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (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: 00630414611693
Basic UDI-DI: 0405686902360VJ
Reference: 11553956
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Tumor Marker Quality Control (TM QC)

IVDR_67_TTN_DUB-C_C_REAG_TM QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414608273
Basic UDI-DI: 0405686902362VN
Reference: 11538186
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

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: 00630414598376
Basic UDI-DI: 0405686901831VV
Reference: 10995510
EMDN: W0102152205
EMDN description: TUMOUR MARKER 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

Atellica IM CA 15-3 Calibrator (CA15-3 CAL)

IVDR_67_TTN_DUB-C_C_REAG_CA 15-3 Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598147
Basic UDI-DI: 0405686901829WA
Reference: 10995487
EMDN: W0102152205
EMDN description: TUMOUR MARKER 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

Atellica IM CA 125II Calibrator (CA 125II CAL)

IVDR_67_TTN_DUB-C_C_REAG_CA 125II Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598109
Basic UDI-DI: 0405686901828W8
Reference: 10995483
EMDN: W0102152205
EMDN description: TUMOUR MARKER 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

ADVIA Centaur Free PSA Calibrator (fPSA Cal)

IVDR_67_TTN_DUB-C_C_REAG_Free PSA Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414557748
Basic UDI-DI: 0405686901852W5
Reference: 10361919
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

N FLC Standard SL

IVDR_27_MAR EB_C_PROF_REAG_N_FLC_Stand_SL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768031441
Basic UDI-DI: 0405686900183V6
Reference: 10482440
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:07

Manufacturer products View details

APO CAL Apolipoprotein Calibrator

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469283RL
Basic UDI-DI: B-469283RL
Reference: 469283
EMDN: W0102152205
EMDN description: TUMOUR MARKER 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

Atellica IM Tumor Marker Quality Control (TM QC)

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414622859
Basic UDI-DI: 0405686902362VN
Reference: 11538187
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 08.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

HER-2/neu CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525473
Basic UDI-DI: 697015090000132H2
Reference: CMB2210
EMDN: W0102152205
EMDN description: HER-2/NEU
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

S100 CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359525572
Basic UDI-DI: 697015090000133H4
Reference: CMB2310
EMDN: W0102152205
EMDN description: PROTEIN S-100 B
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

HER-2/neu CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550499
Basic UDI-DI: 697015090000132H2
Reference: CMB2203
EMDN: W0102152205
EMDN description: HER-2/NEU
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

HER-2/neu CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550512
Basic UDI-DI: 697015090000132H2
Reference: CMB2205
EMDN: W0102152205
EMDN description: HER-2/NEU
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

S100 CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550598
Basic UDI-DI: 697015090000133H4
Reference: CMB2303
EMDN: W0102152205
EMDN description: PROTEIN S-100 B
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

S100 CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359550611
Basic UDI-DI: 697015090000133H4
Reference: CMB2305
EMDN: W0102152205
EMDN description: PROTEIN S-100 B
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100779

1.0 mL/ vial, 6 vials

IVD generalIVDDOn the marketKitReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100779
Basic UDI-DI: B-06974671100779
Reference: DR-CAL-CM-A008
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:08

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100762

1.0 mL/ vial, 6 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100762
Basic UDI-DI: B-06974671100762
Reference: DR-CAL-CM-A005
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details

06974671100755

0.5 mL/vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671100755
Basic UDI-DI: B-06974671100755
Reference: DR-CAL-CM-A010
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:07

Manufacturer products Authorised representative products Authorised representative actors View details