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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

ADVIA Centaur Androstenedione Master Curve Material (ANDRO MCM)

IVDR_67_TTN_DUB-C_B_REAG_ANDRO MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414603438
Basic UDI-DI: 0405686901654VX
Reference: 10997268
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
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

Emit II Plus Specialty Drug Control Negative

IVDR_67_GLA_DUB-C_B_REAG_Specialty Drug Controls Neg and Pos

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601083
Basic UDI-DI: 0405686901191VC
Reference: 10718700
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
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

IMMULITE ACTH Control Module

IVDR_67_LLB_DUB-C_B_REAG_Control Module ACTH

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953090
Basic UDI-DI: 0405686901422V8
Reference: 10385382
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
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 Complexed Prostate-Specific Antigen Quality Control (cPSA QC)

IVDR_67_TTN_DUB-C_C_REAG_cPSA QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598710
Basic UDI-DI: 0405686901840VW
Reference: 10995547
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
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

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

TT4 Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762889
Basic UDI-DI: 697134876222B2889ZT
Reference: MF-222
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

TT3 Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762872
Basic UDI-DI: 697134876221B2872YV
Reference: MF-221
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762865
Basic UDI-DI: 697134876220B2865YK
Reference: MF-220
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762841
Basic UDI-DI: 697134876229C284148
Reference: MF-229
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

PRL Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762834
Basic UDI-DI: 697134876217B28342M
Reference: MF-217
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762827
Basic UDI-DI: 697134876227C28273L
Reference: MF-227
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

LH Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762810
Basic UDI-DI: 697134876215B2810ZA
Reference: MF-215
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762636
Basic UDI-DI: 697134876237C26363U
Reference: MF-237
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

FT4 Control

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762629
Basic UDI-DI: 697134876224B2629ZR
Reference: MF-224
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details