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Bilirubin Total Kit (VOX Method)

105-000826-00、105-000865-00、105-004598-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024820
Basic UDI-DI: 694490400045Bil-T(VOX)*F4
Reference: 105-000826-00
EMDN: W01010203
EMDN description: BILIRUBIN
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

Calcium Kit (Arsenazo Ⅲ Method)

105-000825-00、105-000864-00、105-001600-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024813
Basic UDI-DI: 694490400041CA*********BV
Reference: 105-000825-00
EMDN: W01010303
EMDN description: CALCIUM
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

Urea Kit (Urease-GLDH, UV Method)

105-000824-00、105-000863-00、105-004597-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024806
Basic UDI-DI: 694490400041UREA*******CN
Reference: 105-000824-00
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
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

Albumin Kit (Bromcresol Green Method)

105-000822-00、105-000861-00、105-001597-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024783
Basic UDI-DI: 694490400041ALB********4J
Reference: 105-000822-00
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

Triglycerides Kit (GPO-POD Method)

105-000821-00、105-000860-00、105-001596-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024776
Basic UDI-DI: 694490400041TG*********ZS
Reference: 105-000821-00
EMDN: W01010231
EMDN description: TRIGLYCERIDES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Kit (CHOD-POD Method)

105-000820-00、105-000859-00、105-001595-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024769
Basic UDI-DI: 694490400041TC*********W6
Reference: 105-000820-00
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

α-Hydroxybutyrate Dehydrogenase Kit (DGKC Method)

105-000819-00、105-000858-00、105-004596-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024752
Basic UDI-DI: 694490400041a-HBDH*****EM
Reference: 105-000819-00
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

Lactate Dehydrogenase Kit (IFCC Method)

105-000818-00、105-000857-00、105-004595-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024745
Basic UDI-DI: 694490400041LDH********C9
Reference: 105-000818-00
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

Gamma-Glutamyltransferase Kit (Szasz Method/IFCC stand)

105-000817-00、105-000856-00、105-004594-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024738
Basic UDI-DI: 694490400041GGT********JR
Reference: 105-000817-00
EMDN: W01010116
EMDN description: GAMMA GLUTAMYLTRANSFERASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline phosphatase Kit (IFCC Modified Method)

105-000816-00、105-000855-00、105-004593-00

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024721
Basic UDI-DI: 694490400041ALP********EL
Reference: 105-000816-00
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

Aspartate Aminotransferase Kit (IFCC Method)

105-000815-00、105-000854-00、105-004592-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024714
Basic UDI-DI: 694490400041AST********PT
Reference: 105-000815-00
EMDN: W01010110
EMDN description: ASPARTATE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

Alanine Aminotransferase kit (IFCC Method)

105-000814-00、105-000853-00、105-004591-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904024707
Basic UDI-DI: 694490400041ALT********HG
Reference: 105-000814-00
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

CD80 DETERGENT

105-000748-00、105-000107-00、004C-30-88618、004C-30-88619、105-000106-00、105-011705-00

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039819
Basic UDI-DI: 69449040004CCD80*******FY
Reference: 105-035958-00
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 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

Adenosine Deaminase Kit (Enzymatic Colorimetric Method)

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011563
Basic UDI-DI: 694490400043ADA********WS
Reference: 105-026284-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

5′-Nucleotidase Kit（Enzymatic Colorimetric Method）

105-003176-00、105-003119-00、105-003124-00、105-026281-00、105-026282-00、105-026283-00、105-020475-00、105-003688-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011532
Basic UDI-DI: 6944904000435-NT*******ZV
Reference: 105-026281-00
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem Wash R

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253020692
Basic UDI-DI: 69422530000130NC
Reference: 360115XYR0001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem Wash C

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253020678
Basic UDI-DI: 69422530000129NT
Reference: 360115XYC0001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem Wash B

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253020630
Basic UDI-DI: 69422530000128NR
Reference: 360115XYB0001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem Wash A

Automatic Chemistry Analyzer

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253020593
Basic UDI-DI: 69422530000127NP
Reference: 360115XYA0001
EMDN: W01019001
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

AutoChem HBDH

AutoChem analyzer

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Autobio Biochemistry Co.,Ltd
Manufacturer SRN: CN-MF-000038143
UDI-DI: 06942253005941
Basic UDI-DI: 69422530000062NL
Reference: 360105HBD000S
EMDN: W01010118
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details