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31.07.2026 19:58

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Glucose-6-Phosphate Dehydrogenase (G6PD) Kit (UV Enzymatic Method)

105-009264-00、105-002254-00、105-002255-00、105-002308-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032269
Basic UDI-DI: 69449040004JG6PD*******C3
Reference: 105-002254-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

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

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

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

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

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 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

LDH (IFCC)

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153004384
Basic UDI-DI: 6438153BU00180BW
Reference: 981906
EMDN: W01010119
EMDN description: LACTATE DEHYDROGENASE L ( LDH - L --> P )
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 18:02

Manufacturer products View details

Pankreatische Amylase ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598164109
Basic UDI-DI: B-04050598164109
Reference: K 6410
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IDK® PMN-Elastase ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598168404
Basic UDI-DI: B-04050598168404
Reference: K 6840
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

Lysozym ELISA

Lysozyme ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598169005
Basic UDI-DI: B-04050598169005
Reference: K 6900
EMDN: W01010124
EMDN description: LYSOZYME
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

Chymotrypsin-Aktivität

Chymotrypsin Activity

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598169906
Basic UDI-DI: B-04050598169906
Reference: K 6990
EMDN: W01010112
EMDN description: CHYMOTRYPSIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details