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D-IM4403211HL

Folate Chemiluminescent Binding Assay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403211HL
Basic UDI-DI: B-IM4403211HL
Reference: Folate Chemiluminescent Binding Assay Kit
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403210HJ

Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403210HJ
Basic UDI-DI: B-IM4403210HJ
Reference: IM4403210
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403209HZ

E2 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403209HZ
Basic UDI-DI: B-IM4403209HZ
Reference: IM4403209
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403208HX

Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403208HX
Basic UDI-DI: B-IM4403208HX
Reference: IM4403208
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403207HV

β-HCG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403207HV
Basic UDI-DI: B-IM4403207HV
Reference: IM4403207
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403206HT

human Growth Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403206HT
Basic UDI-DI: B-IM4403206HT
Reference: IM4403206
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403205HR

Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403205HR
Basic UDI-DI: B-IM4403205HR
Reference: IM4403205
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403204HP

FSH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403204HP
Basic UDI-DI: B-IM4403204HP
Reference: IM4403204
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403203HM

PRL (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403203HM
Basic UDI-DI: B-IM4403203HM
Reference: IM4403203
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403202HK

LH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403202HK
Basic UDI-DI: B-IM4403202HK
Reference: IM4403202
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403201HH

Ferritin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403201HH
Basic UDI-DI: B-IM4403201HH
Reference: IM4403201
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403159JB

D-Dimer Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403159JB
Basic UDI-DI: B-IM4403159JB
Reference: IM4403159
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403158J9

BNP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403158J9
Basic UDI-DI: B-IM4403158J9
Reference: IM4403158
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 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403157J7

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-IM4403157J7
Basic UDI-DI: B-IM4403157J7
Reference: IM4403157
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403156J5

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-IM4403156J5
Basic UDI-DI: B-IM4403156J5
Reference: IM4403156
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403155J3

GDF-15 Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403155J3
Basic UDI-DI: B-IM4403155J3
Reference: IM4403155
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403154HZ

NT-proBNP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403154HZ
Basic UDI-DI: B-IM4403154HZ
Reference: IM4403154
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 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403153HX

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403153HX
Basic UDI-DI: B-IM4403153HX
Reference: IM4403153
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 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403152HV

CK-MB (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403152HV
Basic UDI-DI: B-IM4403152HV
Reference: IM4403152
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 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403151HT

MYO (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403151HT
Basic UDI-DI: B-IM4403151HT
Reference: IM4403151
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details