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D-Dimer Assay Kit (Immunoturbidimetry Method)

105-023628-00、105-023629-00、105-023630-00、105-023647-00、105-024608-00、105-024609-00、105-024610-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025461
Basic UDI-DI: 69449040AB75000025M
Reference: 105-023628-00
EMDN: -
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Fibrinogen (FIB) Assay Kit (Clotting Method)

105-023622-00、105-023623-00、105-023624-00、105-023625-00、105-023626-00、105-023627-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025409
Basic UDI-DI: 69449040AB75000065V
Reference: 105-023622-00
EMDN: -
EMDN description: FIBRINOGEN ASSAYS (FACTOR I)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombin Time (TT) Assay Kit (Clotting Method)

105-023619-00、105-023620-00、105-023621-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025379
Basic UDI-DI: 69449040AB75000035P
Reference: 105-023619-00
EMDN: -
EMDN description: THROMBIN TIME / REPTILASE / BATROXBIN TIME
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Activated Partial Thromboplastin Time (APTT) Assay Kit (Clotting Method)

105-023616-00、105-023617-00、105-023618-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025348
Basic UDI-DI: 69449040AB75000045R
Reference: 105-023616-00
EMDN: -
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Prothrombin Time (PT) Assay Kit (Clotting Method)

105-023613-00、105-023614-00、105-023615-00

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025317
Basic UDI-DI: 69449040AB75000055T
Reference: 105-023613-00
EMDN: -
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Sodium electrode

115-084090-00

IVD Class BIVDR 2017/746On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053025126
Basic UDI-DI: 69449040SHYQ-200CNa****ZT
Reference: 115-084090-00
EMDN: -
EMDN description: SODIUM - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

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: -
EMDN description: CHLORIDE - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: POTASSIUM - ELECTRODES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: ELECTROLYTE ELECTRODES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

ToRCH IgG/IgM Negative Control

105-024824-00、105-024825-00、105-024826-00、105-024827-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053020886
Basic UDI-DI: 69449040AB74000185P
Reference: 105-024824-00
EMDN: -
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Coagulation Analyzer

CX-9000、CX-9010、CX-9200、CX-9210

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053019934
Basic UDI-DI: 69449040NXYQ-3806******H7
Reference: CX-9000
EMDN: -
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053016216
Basic UDI-DI: 69449040SHYQ-BA6M******4T
Reference: BS-600M
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

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: -
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:44

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Processing System

TM-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 6903053059053
Basic UDI-DI: 69449040AB3100001ZQ
Reference: TM-1000
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

06936415998950

Resona R7, Nuewa R7, Imagyn R7, Eagus R7

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415998950
Basic UDI-DI: 69449040AB050100335U
Reference: Anesus R7
EMDN: Z11040104
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details