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Maintenance Solution A

105-062954-00

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: 06903053150224
Basic UDI-DI: 69449040AB740007563
Reference: 105-062954-00
EMDN: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Maintenance Solution B

105-062998-00

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: 06903053150217
Basic UDI-DI: 69449040AB740007665
Reference: 105-062998-00
EMDN: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaning Solution B

105-056286-00

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053121743
Basic UDI-DI: 69449040AB75000125Q
Reference: 105-056286-00
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 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol (CLIA)

105-055512-00/105-055510-00/105-066936-00/105-066937-00

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: 06903053118583
Basic UDI-DI: 69449040AB740006866
Reference: 105-055512-00
EMDN: -
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

17α-Hydroxyprogesterone (CLIA)

105-054015-00、105-054017-00、105-053973-00、105-053974-00、105-053978-00、105-053977-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053114035
Basic UDI-DI: 69449040AB74000575Z
Reference: 105-054015-00
EMDN: -
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

W01021521

105-048322-00, 105-048323-00 ,105-053343-00, 105-053344-00, 105-051736-00, 105-051737-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053112116
Basic UDI-DI: 69449040AB740007869
Reference: 105-053463-00
EMDN: -
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

AI Buffer Solution

105-051315-00

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: 06903053098199
Basic UDI-DI: 69449040AB74000735X
Reference: 105-051315-00
EMDN: -
EMDN description: BUFFERS, STAINS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

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: -
EMDN description: COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid-Stimulating Hormone （CLIA）

105-051197-00, 105-051198-00

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053097246
Basic UDI-DI: 69449040AB740006662
Reference: 105-051197-00
EMDN: -
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

AngiotensinⅠ(CLIA)

105-049534-00/105-049536-00

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: 06903053093828
Basic UDI-DI: 69449040AB740006968
Reference: 105-049536-00
EMDN: -
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Angiotensin Ⅱ(CLIA)

105-049533-00、105-049532-00、105-051448-00、

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053093750
Basic UDI-DI: 69449040AB74000715T
Reference: 105-049533-00
EMDN: -
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

B-type Natriuretic Peptide (CLIA)

105-048465-00

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: 06903053089234
Basic UDI-DI: 69449040AB740006764
Reference: 105-048465-00
EMDN: -
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to thyroglobulin (CLIA)

105-048322-00,105-048323-00,105-053343-00, 105-053344-00,105-051736-00,105-051737-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053084642
Basic UDI-DI: 69449040AB740007767
Reference: 105-048322-00
EMDN: -
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

S100 Control

105-032007-00、105-032005-00、105-032009-00、105-032020-00、105-032021-00、105-032024-00、105-032025-00

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: 06903053082754
Basic UDI-DI: 69449040AB740004962
Reference: 105-032024-00
EMDN: -
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate Solution

105-048064-00、105-048065-00

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053082716
Basic UDI-DI: 69449040AB74000605N
Reference: 105-048064-00
EMDN: -
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnT Control

105-046725-00, 105-046726-00, 105-046727-00, 105-046728-00, 105-046731-00, 105-046732-00, 105-046729-00, 105-046730-00, 105-046733-00

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053079693
Basic UDI-DI: 69449040AB74000555V
Reference: 105-046733-00
EMDN: -
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP Control

CL-series machine

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053077552
Basic UDI-DI: 69449040AB74000545T
Reference: 105-046688-00
EMDN: -
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

tIgE Control

CL-series machine

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053077521
Basic UDI-DI: 69449040AB74000535R
Reference: tIgE Control
EMDN: -
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Buffer

105-046470-00

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: 06903053077453
Basic UDI-DI: 69449040AB74000505K
Reference: 105-046470-00
EMDN: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Total-P1NP/Osteocalcin/β-CTx Multi Control

105-045127-00、105-045128-00、105-045130-00 、105-045129-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074087
Basic UDI-DI: 69449040AB74000645W
Reference: 105-045130-00
EMDN: -
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details