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31.07.2026 22:52

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Chloride electrode

115-084091-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025119
Basic UDI-DI: 69449040SHYQ-200CCl****Z5
Reference: 115-084091-00
EMDN: W0101070103
EMDN description: CHLORIDE - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Potassium electrode

115-084089-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025102
Basic UDI-DI: 69449040SHYQ-200CK*****FR
Reference: 115-084089-00
EMDN: W0101070106
EMDN description: POTASSIUM - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Reference electrode

115-084088-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025096
Basic UDI-DI: 69449040SHYQ-200CREF***ZF
Reference: 115-084088-00
EMDN: W0101070199
EMDN description: ELECTROLYTE ELECTRODES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

M-53 CLEANSER

Please see UDI-DIs for details.

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024709
Basic UDI-DI: 69449040XQSJ-CLEANSER**T3
Reference: 105-026315-00
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

M-53LEO(Ⅱ) LYSE

Please see UDI-DIs for details

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024648
Basic UDI-DI: 69449040XQSJ-003BM-5S**VC
Reference: 105-026318-00
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

M-30D DILUENT

Please see UDI-DIs for details.

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024372
Basic UDI-DI: 69449040XQSJ-003SM-3S**62
Reference: 105-026309-00
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

BC-BF 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: 06903053022811
Basic UDI-DI: 69449040XQSJ-003J******A4
Reference: 105-028639-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

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: 06903053022460
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028604-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

ESR Solution Reagent

Please see UDI-DIs for details

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022194
Basic UDI-DI: 69449040XQSJ-ESRSR*****TA
Reference: 105-026689-00
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

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: 06903053011297
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 105-026332-00
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron-specific enolase(CLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904091129
Basic UDI-DI: 69449040004L-NSE*******DR
Reference: 105-005669-00
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 72-4(CLIA)

105-005668-00、105-005685-00、105-005919-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904091112
Basic UDI-DI: 69449040004L-CA72-4****PX
Reference: 105-005668-00
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Function Multi Control

105-007383-00、 105-007379-00、105-007371-00、105-007375-00、105-007384-00、105-007380-00、105-007372-00、105-007376-00

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904083124
Basic UDI-DI: 69449040004L-TFM-Con***V9
Reference: 105-007371-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

LC LYSE

105-004887-00、105-011300-00

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904082981
Basic UDI-DI: 69449040AB70000043Q
Reference: 105-004887-00
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoassay Multi Control

105-005943-00、 105-005929-00、105-005944-00、105-005930-00

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065595
Basic UDI-DI: 69449040004L-IM-Con****JZ
Reference: 105-005929-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Marker Multi Control

105-005941-00、105-005927-00、105-005942-00、105-005928-00

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065571
Basic UDI-DI: 69449040004L-CM-Con****DK
Reference: 105-005927-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroid peroxidase(CLIA)

105-005665-00、105-005682-00、105-005916-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065274
Basic UDI-DI: 69449040004L-Anti-TPO**6B
Reference: 105-005665-00
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroglobulin(CLIA)

105-005664-00、105-005681-00、105-005915-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065267
Basic UDI-DI: 69449040004L-Anti-Tg***4M
Reference: 105-005664-00
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroglobulin(CLIA)

105-005663-00、105-005680-00、105-005914-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065250
Basic UDI-DI: 69449040004L-Tg********EJ
Reference: 105-005663-00
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine kinase MB(CLIA)

105-005662-00、105-005679-00、105-005913-00

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065243
Basic UDI-DI: 69449040004L-CK-MB*****BS
Reference: 105-005662-00
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details