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Starrsed Control Level A - Blister 6*QRR 049002

IVD Class ANot specifiedOn the marketDirect markingHuman tissuesProfessional testingReagentSingle use

Manufacturer: RR Mechatronics Manufacturing BV
Manufacturer SRN: NL-MF-000023105
UDI-DI: 08719189137170
Basic UDI-DI: 8719189137E4TB8YG8
Reference: A0026578
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 04:47

Manufacturer products View details

Hematology Calibrator

CH-CAL

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066777089
Basic UDI-DI: 697806677HE001JV
Reference: 6530-PA00004
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 360 Control

IVDR_67_TTN_DUB-C_B_REAG_Control

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600833
Basic UDI-DI: 0405686901690W3
Reference: 11170853
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
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

ADVIA 360/560 Calibrator

IVDR_67_TTN_DUB-C_B_REAG_Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600826
Basic UDI-DI: 0405686901679WF
Reference: 11170852
EMDN: W0103010507
EMDN description: WHOLE BLOOD 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

ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN2 Control)

IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in-1 Con Abnor 2

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414473413
Basic UDI-DI: 0405686900800VB
Reference: 10318905
EMDN: W0103010502
EMDN description: ABNORMAL BLOOD CONTROLS
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

ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN1 Control)

IVDR_67_TTN_DUB-C_B_REAG_TESTpt 3-in -1 Control Abnor 1

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414473406
Basic UDI-DI: 0405686900801VD
Reference: 10330063
EMDN: W0103010502
EMDN description: ABNORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (Norm Control)

IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in -1 Con Normal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414473390
Basic UDI-DI: 0405686900799WK
Reference: 10316217
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i SETpoint Calibrator

IVDR_67_TTN_DUB-C_B_REAG_SETpoint Calibrator

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224343
Basic UDI-DI: 0405686900797WF
Reference: 10312285
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i OPTIpoint

IVDR_67_TTN_DUB-C_B_REAG_OPTIpoint

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224329
Basic UDI-DI: 0405686900791W3
Reference: 10312283
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Calibrator

CH-CAL

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066777065
Basic UDI-DI: 697806677HE001JV
Reference: 6530-PA00002
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Calibrator

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066777072
Basic UDI-DI: 697806677HE001JV
Reference: 6530-PA00003
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER Body Fluid Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628030PU
Basic UDI-DI: B-628030PU
Reference: 628030
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER LIN-X Linearity Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628029QB
Basic UDI-DI: B-628029QB
Reference: 628029
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER Retic-X Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628028Q9
Basic UDI-DI: B-628028Q9
Reference: 628028
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER 6C Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628027Q7
Basic UDI-DI: B-628027Q7
Reference: 628027
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

S-CAL Calibrator

IVD generalIVDDNo longer on the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628026Q5
Basic UDI-DI: B-628026Q5
Reference: 628026
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER Latron CP-X Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-628024PZ
Basic UDI-DI: B-628024PZ
Reference: 628024
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter Retic-C Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-624671QC
Basic UDI-DI: B-624671QC
Reference: 624671
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

COULTER S-CAL Calibrator Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-624519Q5
Basic UDI-DI: B-624519Q5
Reference: 624519
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Coulter 5C Cell Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-624506PU
Basic UDI-DI: B-624506PU
Reference: 624506
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details