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836 device results listed.

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BC-5D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022569
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028614-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

BC-5D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022552
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028613-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

B30 Hematology Control

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011372
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 105-026340-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

BC-5D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022545
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028612-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

B30 Hematology Control

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011365
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 105-026339-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

BC-3D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022521
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028610-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

B30 Hematology Control

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011358
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 105-026338-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

BC-3D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022514
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028609-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

B30 Hematology Control

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011341
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 105-026337-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

BC-3D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022507
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028608-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:26

Manufacturer products Authorised representative products Authorised representative actors View details

B30 Hematology Control

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011334
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 105-026336-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:26

Manufacturer products Authorised representative products Authorised representative actors View details

BC-3D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022491
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028607-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

S30 Calibrator

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011327
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 3mL× 1
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:17

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA 120/2120/2120i TESTpoint Reticulocyte Controls (High)

IVDR_67_TTN_DUB-C_B_REAG_Reticulocyte Control High

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414224442
Basic UDI-DI: 0405686900796WD
Reference: 10312295
EMDN: W0103010506
EMDN description: RETICULOCYTE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Control

ED-60D Control H

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413815810
Basic UDI-DI: B-06944413815810
Reference: ED-60D Control N
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 14:34

Manufacturer products Authorised representative products Authorised representative actors View details

BC-3D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022484
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028606-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

S30 Calibrator

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011310
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 3mL× 1
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

BC-3D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022477
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028605-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

S50 Calibrator

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011303
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 105-026333-00
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

SEDiTROL

SEDiTROL ESR Controls

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Alcor Scientific
Manufacturer SRN: US-MF-000029295
UDI-DI: 00896406002492
Basic UDI-DI: 0896406002SEDiTROLC4
Reference: DSC06
EMDN: W0103010599
EMDN description: HAEMATOLOGY CONTROLS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 21:04

Manufacturer products Authorised representative products Authorised representative actors View details