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D-IM4492156LZ

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492156LZ
Basic UDI-DI: B-IM4492156LZ
Reference: IM4492156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491157LU

High Sensitive Troponin T Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491157LU
Basic UDI-DI: B-IM4491157LU
Reference: IM4491157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491156LS

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491156LS
Basic UDI-DI: B-IM4491156LS
Reference: IM4491156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408154K4

NT-proBNP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408154K4
Basic UDI-DI: B-IM4408154K4
Reference: IM4408154
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: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408153K2

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408153K2
Basic UDI-DI: B-IM4408153K2
Reference: IM4408153
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408152JY

CK-MB (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408152JY
Basic UDI-DI: B-IM4408152JY
Reference: IM4408152
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408151JW

MYO (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408151JW
Basic UDI-DI: B-IM4408151JW
Reference: IM4408151
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407303JN

hs-CRP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407303JN
Basic UDI-DI: B-IM4407303JN
Reference: IM4407303
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407158K5

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407158K5
Basic UDI-DI: B-IM4407158K5
Reference: IM4407158
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407157K3

High Sensitive Troponin T Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407157K3
Basic UDI-DI: B-IM4407157K3
Reference: IM4407157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407156JZ

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407156JZ
Basic UDI-DI: B-IM4407156JZ
Reference: IM4407156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407154JV

NT-proBNP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407154JV
Basic UDI-DI: B-IM4407154JV
Reference: IM4407154
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: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407153JT

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407153JT
Basic UDI-DI: B-IM4407153JT
Reference: IM4407153
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407152JR

CK-MB (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407152JR
Basic UDI-DI: B-IM4407152JR
Reference: IM4407152
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407151JP

MYO (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407151JP
Basic UDI-DI: B-IM4407151JP
Reference: IM4407151
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406303JF

hs-CRP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406303JF
Basic UDI-DI: B-IM4406303JF
Reference: IM4406303
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406158JW

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406158JW
Basic UDI-DI: B-IM4406158JW
Reference: IM4406158
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406157JU

High Sensitive Troponin T Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406157JU
Basic UDI-DI: B-IM4406157JU
Reference: IM4406157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406156JS

High Sensitive Troponin I Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406156JS
Basic UDI-DI: B-IM4406156JS
Reference: IM4406156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406154JN

NT-proBNP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406154JN
Basic UDI-DI: B-IM4406154JN
Reference: IM4406154
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: 14.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details