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D-IM4407127JS

Pepsinogen I Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407127JS
Basic UDI-DI: B-IM4407127JS
Reference: IM4407127
EMDN: W0102069006
EMDN description: PEPSINOGEN
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-IM4407115JK

HE4 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407115JK
Basic UDI-DI: B-IM4407115JK
Reference: IM4407115
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
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-IM4407114JH

CA 242 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407114JH
Basic UDI-DI: B-IM4407114JH
Reference: IM4407114
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
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-IM4407113JF

CA 72-4 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407113JF
Basic UDI-DI: B-IM4407113JF
Reference: IM4407113
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
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-IM4407112JD

proGRP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407112JD
Basic UDI-DI: B-IM4407112JD
Reference: IM4407112
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
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-IM4407111JB

SCC Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407111JB
Basic UDI-DI: B-IM4407111JB
Reference: IM4407111
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
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-IM4407110J9

CA 50 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407110J9
Basic UDI-DI: B-IM4407110J9
Reference: IM4407110
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
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-IM4407109JQ

CYFRA21-1 Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407109JQ
Basic UDI-DI: B-IM4407109JQ
Reference: IM4407109
EMDN: W0102030111
EMDN description: CYFRA 21-1
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-IM4407108JN

NSE Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407108JN
Basic UDI-DI: B-IM4407108JN
Reference: IM4407108
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
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-IM4407074JW

S100 Protein Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407074JW
Basic UDI-DI: B-IM4407074JW
Reference: IM4407074
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
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-IM4407073JU

Pregnancy Associated Plasma Protein-A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407073JU
Basic UDI-DI: B-IM4407073JU
Reference: IM4407073
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
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-IM4407099KE

Unconjugated Estriol Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407099KE
Basic UDI-DI: B-IM4407099KE
Reference: IM4407099
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
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-IM4407072JS

Free β-HCG Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407072JS
Basic UDI-DI: B-IM4407072JS
Reference: IM4407072
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
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-IM4407059K2

Tg (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407059K2
Basic UDI-DI: B-IM4407059K2
Reference: IM4407059
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407058JY

iPTH Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407058JY
Basic UDI-DI: B-IM4407058JY
Reference: IM4407058
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
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-IM4407043JK

HEV IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407043JK
Basic UDI-DI: B-IM4407043JK
Reference: IM4407043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
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-IM4407041JF

Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407041JF
Basic UDI-DI: B-IM4407041JF
Reference: IM4407041
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
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-IM4407040JD

Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407040JD
Basic UDI-DI: B-IM4407040JD
Reference: IM4407040
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
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-IM4407022JB

Serum amyloid A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407022JB
Basic UDI-DI: B-IM4407022JB
Reference: IM4407022
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
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-IM4407017JJ

HEV IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407017JJ
Basic UDI-DI: B-IM4407017JJ
Reference: IM4407017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
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