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Automatic Hematology Analyzer F-DC Diluent

BL2200243: 1 L×1 BL2201243: 20 L×1

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617476429
Basic UDI-DI: 69506174BL2202437A
Reference: BL2200243: 1 L×1
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Hematology Analyzer F-DC Diluent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617476436
Basic UDI-DI: 69506174BL2202437A
Reference: BL2201243: 20 L×1
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.09.2026 20:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4411116FN

TOXO IgG Antibody Chemiluminescent Immunoassay Kit

IVD Annex II List BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4411116FN
Basic UDI-DI: B-EIM4411116FN
Reference: EIM4411116
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4499202MY

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4499202MY
Basic UDI-DI: B-IM4499202MY
Reference: IM4499202
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4499076NK

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4499076NK
Basic UDI-DI: B-IM4499076NK
Reference: IM4499076
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4499051N3

Thyroid Function Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4499051N3
Basic UDI-DI: B-IM4499051N3
Reference: IM4499051
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4498268NP

Rheumatoid Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4498268NP
Basic UDI-DI: B-IM4498268NP
Reference: IM4498268
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4498202MR

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4498202MR
Basic UDI-DI: B-IM4498202MR
Reference: IM4498202
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4498076NC

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4498076NC
Basic UDI-DI: B-IM4498076NC
Reference: IM4498076
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4498075NA

Cardiac Markers Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4498075NA
Basic UDI-DI: B-IM4498075NA
Reference: IM4498075
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4498051MU

Thyroid Function Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4498051MU
Basic UDI-DI: B-IM4498051MU
Reference: IM4498051
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4497268NG

Rheumatoid Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4497268NG
Basic UDI-DI: B-IM4497268NG
Reference: IM4497268
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4497202MJ

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4497202MJ
Basic UDI-DI: B-IM4497202MJ
Reference: IM4497202
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4497076N5

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKit

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4497076N5
Basic UDI-DI: B-IM4497076N5
Reference: IM4497076
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4497075N3

Cardiac Markers Control Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4497075N3
Basic UDI-DI: B-IM4497075N3
Reference: IM4497075
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4497051MM

Thyroid Function Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4497051MM
Basic UDI-DI: B-IM4497051MM
Reference: IM4497051
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4496471N8

Hypertension Marker Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4496471N8
Basic UDI-DI: B-IM4496471N8
Reference: IM4496471
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4496208MP

Anti-Müllerian Hormone (AMH) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4496208MP
Basic UDI-DI: B-IM4496208MP
Reference: IM4496208
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4496076MW

Anemia Markers Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4496076MW
Basic UDI-DI: B-IM4496076MW
Reference: IM4496076
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4496202MB

Hormones Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4496202MB
Basic UDI-DI: B-IM4496202MB
Reference: IM4496202
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:38

Manufacturer products Authorised representative products Authorised representative actors View details