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04.08.2026 02:01

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CK-MB CLIA Microparticles

IVD Class CNot specifiedOn the market

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548014
Basic UDI-DI: 697015090000037H7
Reference: CMH0305
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

HS-cTnT CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548298
Basic UDI-DI: 697015090000260HC
Reference: CMH0603
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

H-FABP CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548199
Basic UDI-DI: 697015090000259HT
Reference: CMH1103
EMDN: W01021302
EMDN description: HEART-TYPE FATTY ACID BINDING PROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

NT-proBNP CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548090
Basic UDI-DI: 697015090000038H9
Reference: CMH0403
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547994
Basic UDI-DI: 697015090000037H7
Reference: CMH0303
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

BNP CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547796
Basic UDI-DI: 697015090000082HC
Reference: CMH0803
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

MYO CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547499
Basic UDI-DI: 697015090000035H3
Reference: CMH0103
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547390
Basic UDI-DI: 697015090000036H5
Reference: CMH0203
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine kinase MB(CLIA)

105-005662-00、105-005679-00、105-005913-00

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904065243
Basic UDI-DI: 69449040004L-CK-MB*****BS
Reference: 105-005662-00
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin(CLIA)

105-005661-00、105-005678-00、105-005912-00

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: 06944904065236
Basic UDI-DI: 69449040004L-MYO*******P4
Reference: 105-005661-00
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

B-type natriuretic peptide (CLIA)

105-005660-00/105-005677-00

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: 06944904065229
Basic UDI-DI: 69449040AB74000075J
Reference: 105-005660-00
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Troponin I(CLIA)

105-005659-00、105-005676-00、105-005910-00

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: 06944904065212
Basic UDI-DI: 69449040004L-TnI*******5G
Reference: 105-005659-00
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin (MYO) Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-012736-00、105-002238-00、105-002239-00、105-012735-00、105-004499-00、105-004500-00、105-002302-00

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: 06944904032160
Basic UDI-DI: 69449040004JMYO********Z5
Reference: 105-002238-00
EMDN: W01021304
EMDN description: MYOGLOBIN
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

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: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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

N-terminal pro B-type natriuretic peptide (CLIA)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053028929
Basic UDI-DI: 69449040AB74000155H
Reference: 105-027044-00
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reaction Protein（hs-CRP）Kit (Latex Particle-Enhanced Immunonephelometry Method）

105-025167-00、105-019042-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053027076
Basic UDI-DI: 69449040AB70000163X
Reference: 105-025167-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）

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: 06944904031675
Basic UDI-DI: 694490400043HS-CRP*****PP
Reference: 105-001942-00
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
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

06926802603390

NT-proBNP (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603390
Basic UDI-DI: 69268026MD71B00001U5
Reference: MCL01701E
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603192

TnI (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603192
Basic UDI-DI: 69268026MD71A00001TQ
Reference: MCL01601E
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603154

MYO（CLIA）

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603154
Basic UDI-DI: 69268026MD71D00001UX
Reference: MCL01901E
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details