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17.07.2026 13:39

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Tumor Marker Multi Control II

105-010146-00, 105-010156-00 105-010151-00, 105-010161-00

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: 06936415908218
Basic UDI-DI: 69449040004V-TMII-Con**DV
Reference: 105-010146-00
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 50 (CLIA)

105-010090-00、105-010100-00、105-010140-00

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: 06936415908096
Basic UDI-DI: 69449040004V-CA50******UL
Reference: 105-010090-00
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma Antigen (CLIA)

105-010085-00、105-010095-00、105-010135-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908065
Basic UDI-DI: 69449040004V-SCCA******UU
Reference: 105-010085-00
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

ProGRP(CLIA)

105-010084-00、105-010094-00、105-010134-00、105-010145-00、105-010155-00、105-010150-00、105-010160-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908058
Basic UDI-DI: 69449040004V-ProGRP****FH
Reference: 105-010084-00
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Reproductive Multi Control

105-004266-00、105-004272-00、105-008888-00、 105-008890-00、105-004267-00、105-004273-00、105-008889-00、105-008891-00

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908034
Basic UDI-DI: 69449040004H-RM-Con****NJ
Reference: 105-008890-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-006175-00、105-002244-00、105-002245-00、105-006176-00、105-004505-00、105-004506-00、105-002311-00

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: 06936415904159
Basic UDI-DI: 69449040004JFER********AD
Reference: 105-006175-00
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Transferrin Kit (Immunoturbidimetric Assay Method)

105-006177-00、105-002246-00、105-002247-00、105-006178-00、105-004507-00、105-004508-00、105-002317-00

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: 06936415904142
Basic UDI-DI: 69449040004JTRF********T4
Reference: 105-006177-00
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Microalbumin Kit (Immunoturbidimetric Assay Method)

105-006173-00、105-002242-00、105-002243-00、105-006174-00、105-004503-00、105-004504-00、105-002315-00、105-002316-00

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: 06936415904128
Basic UDI-DI: 69449040004JMALB*******NV
Reference: 105-006173-00
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Liver Fibrosis Multi Control

105-010229-00、105-010249-00、105-010239-00、105-010259-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900724
Basic UDI-DI: 69449040004S-LFM-Con***W4
Reference: 105-010249-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin(CLIA)

105-010703-00、105-010730-00、105-010219-00、105-010228-00、105-010248-00、105-010238-00、 105-010258-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900588
Basic UDI-DI: 69449040004S-PCT*******M3
Reference: 105-010703-00
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Collagen Type IV (CLIA)

105-010718-00、105-010745-00、105-010707-00、105-010734-00

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: 06936415900564
Basic UDI-DI: 69449040004S-C4********6S
Reference: 105-010718-00
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Peptide of Procollagen Type III (CLIA)

105-010717-00、 105-010744-00、105-010706-00、105-010733-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900540
Basic UDI-DI: 69449040004S-PIIINP****VT
Reference: 105-010717-00
EMDN: W0102120104
EMDN description: PROCOLLAGEN III AMINO TERMINAL PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Hyaluronic acid (CLIA)

105-010716-00、105-010743-00、105-010705-00、105-010732-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900526
Basic UDI-DI: 69449040004S-HA********KX
Reference: 105-010716-00
EMDN: W0102120103
EMDN description: HYALURONIC ACID
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Laminin (CLIA)

105-010715-00、105-010742-00、105-010704-00、105-010731-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900502
Basic UDI-DI: 69449040004S-LN********YW
Reference: 105-010715-00
EMDN: W0102120199
EMDN description: LIVER FUNCTION - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen Ⅱ (CLIA)

105-010087-00、105-010097-00、105-010137-00

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: 06936415900489
Basic UDI-DI: 69449040004V-PG2*******7T
Reference: 105-010087-00
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Pepsinogen I (CLIA)

105-010086-00、105-010096-00、105-010136-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900465
Basic UDI-DI: 69449040004V-PG1*******78
Reference: 105-010086-00
EMDN: W0102069006
EMDN description: PEPSINOGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Reverse Triiodothyronine (CLIA)

105-010692-00、105-010719-00、105-010213-00、105-010220-00、105-010240-00、 105-010250-00105-010230-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900441
Basic UDI-DI: 69449040004S-rT3*******8N
Reference: 105-010692-00
EMDN: W01020404
EMDN description: REVERSE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Analyzer

UA-610T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053159715
Basic UDI-DI: 69449040AB310000625
Reference: UA-610T
EMDN: -
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-6000、BC-6000Plus、BC-6200、BC-6100、BC-6100Plus、Counter 60 AL

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053159388
Basic UDI-DI: 69449040AB3000019ZW
Reference: Counter 60 AL
EMDN: -
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (CLIA)

105-010711-00、105-010738-00、105-018808-00、105-010697-00、105-010724-00、 105-018809-00、105-018810-00、105-018811-00

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: 06903053158695
Basic UDI-DI: 69449040004S-AMH*******7J
Reference: 105-065971-00
EMDN: -
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details