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ADVIA Autoslide Wright Giemsa Buffer

IVDR_67_TTN_DUB-C_A_REAG_Autoslide Wright Giemsa Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414503950
Basic UDI-DI: 0405686900770VT
Reference: 10327572
EMDN: W01030705
EMDN description: FIXING REAGENTS (HISTOLOGY/CYTOLOGY)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Autoslide Modified Wright Stain

IVDR_67_TTN_DUB-C_A_REAG_A.slide Modified Wright's Stn

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414503936
Basic UDI-DI: 0405686900753VT
Reference: 10327576
EMDN: W0103010302
EMDN description: ROMANOWSKY STAINS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur H2n 1,2 Quality Control

IVDR_67_TTN_DUB-C_C_REAG_H2n QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414471211
Basic UDI-DI: 0405686901854W9
Reference: 10308992
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur BR

IVDR_67_TTN_DUB-C_C_KIT_BR

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414196664
Basic UDI-DI: 0405686901799WS
Reference: 10334837
EMDN: W0102030110
EMDN description: CANCER ANTIGEN 27.29
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension A1C Kit

IVDR_67_GLA_DUB-C_C_KIT_A1C

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414006659
Basic UDI-DI: 0405686900197VH
Reference: 10720883
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BR 27.29 (BR)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598048
Basic UDI-DI: 0405686901799WS
Reference: 10995477
EMDN: W0102030110
EMDN description: CANCER ANTIGEN 27.29
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM BR 27.29 (BR)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598055
Basic UDI-DI: 0405686901799WS
Reference: 10995478
EMDN: W0102030110
EMDN description: CANCER ANTIGEN 27.29
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 21.07.2026 22:46

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

Dimension Direct Bilirubin Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_DBI

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768020551
Basic UDI-DI: 0405686901093VB
Reference: 10444956
EMDN: W01010203
EMDN description: BILIRUBIN
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

Dimension Immunoglobulin A Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_IGA

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005688
Basic UDI-DI: 0405686901124UV
Reference: 10444982
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
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

Emit d.a.u. Amphetamine Class Assay

IVDR_67_GLA_DUB-C_B_KIT_Amphetamine Class Assay

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768017148
Basic UDI-DI: 0405686901047V4
Reference: 10445253
EMDN: W0102090101
EMDN description: AMPHETAMINES GROUP
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

Dimension Immunoglobulin G Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_IGM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768005701
Basic UDI-DI: 0405686901126UZ
Reference: 10444983
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
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

IMMULITE 2000 FSH

IVDR_67_LLB_DUB-C_B_REAG_KIT_follicle stimulating hor

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961514
Basic UDI-DI: 0405686901382VM
Reference: 10381180
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - 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

IMMULITE 2000 Anti-TPO Ab

IVDR_67_LLB_DUB-C_B_KIT_Anti-TPO Ab

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414962153
Basic UDI-DI: 0405686901370VE
Reference: 10381649
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
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

IMMULITE Gastrin Control Module

IVDR_67_LLB_DUB-C_B_REAG_Gastrin Control Module

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953199
Basic UDI-DI: 0405686901427VJ
Reference: 10385331
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
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

IMMULITE 2000 DHEA-SO4

IVDR_67_LLB_DUB-C_B_REAG_KIT_DHEA-SO4

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961309
Basic UDI-DI: 0405686901376VS
Reference: 10381193
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - 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 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

Dimension Alkaline Phosphatase calibrator

IVDR_67_GLA_DUB-C_B_REAG_ALPI_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768039027
Basic UDI-DI: 0405686900199VM
Reference: 10714028
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
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