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01.08.2026 18:27

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UIBC Calibrator

105-009265-00、105-004515-00、105-004516-00、105-002306-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904031521
Basic UDI-DI: 69449040004JUIBC*******XA
Reference: 105-002306-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Pancreatic Amylase Calibrator

please see UDI-DI for details

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: 06903053115339
Basic UDI-DI: 69449040AB710000547
Reference: 105-053163-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Storage Solution

105-051464-00/105-051463-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053098175
Basic UDI-DI: 69449040AB74000745Z
Reference: 105-051464-00
EMDN: W0101070304
EMDN description: COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Detergent B

please see UDI-DI for details

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053097017
Basic UDI-DI: 69449040AB710000343
Reference: 105-034926-00
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Iron (Fe) Kit (Colorimetric Assay)

105-002198-00、105-002199-00、105-002200-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037752
Basic UDI-DI: 69449040004EFe*********YX
Reference: 105-002198-00
EMDN: W01010216
EMDN description: IRON (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Fructosamine (FUN) Kit (Colorimetric Assay)

105-002195-00、105-002196-00、105-002197-00、105-020477-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037721
Basic UDI-DI: 69449040004EFUN********G8
Reference: 105-002195-00
EMDN: W01010210
EMDN description: FRUCTOSAMINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Carbon Dioxide (CO2) Kit (Enzymic Method)

105-002189-00、105-002190-00、105-002191-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037660
Basic UDI-DI: 69449040004ECO2********LD
Reference: 105-002189-00
EMDN: W0101060601
EMDN description: CARBON DIOXIDE - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Cholinesterase (CHE) Kit (DGKC Method)

105-002162-00、105-002163-00、105-002164-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037431
Basic UDI-DI: 69449040004ECHE********SY
Reference: 105-002162-00
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Lipase Kit (Enzymatic Colorimetric Assay Method)

105-002171-00、105-002172-00、105-002173-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037509
Basic UDI-DI: 69449040004GLIP********EW
Reference: 105-002171-00
EMDN: W01010123
EMDN description: LIPASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

α-L-Fucosidase Kit (CNPF Method)

please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904034959
Basic UDI-DI: 694490400043AFU********F3
Reference: 105-003123-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

β-HB Calibrator

105-006184-00、105-004513-00、105-004514-00、105-002319-00、105-002320-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032375
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-002319-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:44

Manufacturer products Authorised representative products Authorised representative actors View details

Angiotensin Converting Enzyme Kit (Enzymatic Colorimetric Assay Method)

105-006179-00、105-002248-00、105-002249-00、105-006180-00、105-004509-00、105-004510-00、105-002313-00、105-002314-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032207
Basic UDI-DI: 69449040004JACE********SA
Reference: 105-002248-00
EMDN: W01010109
EMDN description: ANGIOTENSIN CONVERTING ENZYME (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin A1c Kit (Enzymatic Assay Method)

Please see UDI-DIs for details

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904029498
Basic UDI-DI: 69449040004GHbAlc******HA
Reference: 105-002166-00
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Multi Sera Calibrator

105-001144-00

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026046
Basic UDI-DI: 694490400046MultiCal***XZ
Reference: 105-001144-00
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Lipids Calibrator

105-001128-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025889
Basic UDI-DI: 694490400046LipidsCal**VP
Reference: 105-001128-00
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB Kit (IFCC Method)

105-004616-00、105-000870-00、105-004601-00、105-001132-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025261
Basic UDI-DI: 694490400045CK-MB******U8
Reference: 105-000870-00
EMDN: W01010114
EMDN description: CREATINE KINASE - MB ACTIVITY (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase Kit（IFCC Method)

105-004615-00、105-000869-00、105-004600-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025254
Basic UDI-DI: 694490400045CK*********RK
Reference: 105-000869-00
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Creatinine Kit (Sarcosine Oxidase Method)

105-004614-00、105-000868-00、105-004612-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025247
Basic UDI-DI: 694490400045CREA(SOX)**57
Reference: 105-000868-00
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Total Bile Acids Kit (Enzymatic cycling assay)

105-004613-00、105-000867-00、105-001603-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025230
Basic UDI-DI: 694490400045TBA********HS
Reference: 105-000867-00
EMDN: W01010202
EMDN description: BILE ACIDS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose Kit (GOD-POD Method)

105-000849-00、105-000888-00、105-001624-00

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904025056
Basic UDI-DI: 694490400041GLU(GOD)***US
Reference: 105-000849-00
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details