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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

Streck

218750

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000648
Basic UDI-DI: 0844509012EXT5Y
Reference: 218750
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Streck

225480

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000358
Basic UDI-DI: 08445090STKRQM
Reference: 225485
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

Streck

212431

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 00844509000280
Basic UDI-DI: 08445090CX8Z
Reference: 212420
EMDN: W0103010501
EMDN description: NORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:20

Manufacturer products Authorised representative products Authorised representative actors View details

R&D Retic-I

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

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 00815762024153
Basic UDI-DI: 0815762020RIBS
Reference: Many
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

CBC-CAL PLUS

NCAL1

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissues

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 00815762023446
Basic UDI-DI: 0815762028CPC3
Reference: Many
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

Tech-Cal

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

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 00815762020674
Basic UDI-DI: 0815762020CT02A
Reference: 0CT010TA3
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 16.07.2026 04:19

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i® autoRETIC

IVDR_67_TTN_DUB-C_A_REAG_autoRETIC

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414222905
Basic UDI-DI: 0405686900767W6
Reference: 10330709
EMDN: W0103010502
EMDN description: ABNORMAL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Tech-Cal

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

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 10815762021609
Basic UDI-DI: 0081576202TCV11SK
Reference: TCV11
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 15.07.2026 22:21

Manufacturer products Authorised representative products Authorised representative actors View details

R&D Retic-I

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

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 00815762021220
Basic UDI-DI: 0081576202RI00QM
Reference: RI001
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 15.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

R&D Retic

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

Manufacturer: R&D Systems, Inc.
Manufacturer SRN: US-MF-000024485
UDI-DI: 00815762021206
Basic UDI-DI: 0081576202RE00PZ
Reference: RE003
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: France
Authorised representative: BIO-TECHNE SAS
Last updated: 15.07.2026 22:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-QS2102-01PJ

RQ-6D，RQ-NRBC，RQ-RET，RQ-BF

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-QS2102-01PJ
Basic UDI-DI: B-QS2102-01PJ
Reference: /
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 15.07.2026 05:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-QS2102-02PL

RC-CAL，RC-CAL RET

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-QS2102-02PL
Basic UDI-DI: B-QS2102-02PL
Reference: /
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 15.07.2026 05:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-HC-111ELTP

Hemoglobin A2 elevated control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HC-111ELTP
Basic UDI-DI: B-HC-111ELTP
Reference: HC-111EL
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:53

Manufacturer products View details

D-HC-102ZU

AFSC Haemoglobin control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HC-102ZU
Basic UDI-DI: B-HC-102ZU
Reference: HC-102
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:53

Manufacturer products View details

D-HC-111ZV

Hemoglobin A2 normal control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Seleo S.r.l.
Manufacturer SRN: IT-MF-000045668
UDI-DI: D-HC-111ZV
Basic UDI-DI: B-HC-111ZV
Reference: HC-111
EMDN: W0103010504
EMDN description: HAEMOGLOBIN CONTROLS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 00:53

Manufacturer products View details

D-EBL2297003BS

Hematology Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL2297003BS
Basic UDI-DI: B-EBL2297003BS
Reference: EBL2297003
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-EBL2297002BQ

Hematology Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EBL2297002BQ
Basic UDI-DI: B-EBL2297002BQ
Reference: EBL2297002
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details