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IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447790R6
Basic UDI-DI: B-447790R6
Reference: 447790
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447750QS
Basic UDI-DI: B-447750QS
Reference: 447750
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447740QP
Basic UDI-DI: B-447740QP
Reference: 447740
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447780R3
Basic UDI-DI: B-447780R3
Reference: 447780
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447710QE
Basic UDI-DI: B-447710QE
Reference: 447710
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

ß2-microglobulin

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: D-3000-2307D8
Basic UDI-DI: B-3000-2307D8
Reference: 3000-2307
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 11.07.2026 18:06

Manufacturer products View details

ß2-microglobulin Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Biokit S.A.
Manufacturer SRN: ES-MF-000002406
UDI-DI: D-3000-2192DF
Basic UDI-DI: B-3000-2192DF
Reference: 3000-2192
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 11.07.2026 18:06

Manufacturer products View details

Serum Amyloid A Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346120
Basic UDI-DI: B-20850076346120
Reference: CDSAA-401a
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Heparin-Binding Protein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346113
Basic UDI-DI: B-20850076346113
Reference: CDHBP-301a
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

SARS‐CoV‐2 Antigen Rapid Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Lvshiyuan Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000028164
UDI-DI: 16974169670101
Basic UDI-DI: B-16974169670101
Reference: 1 set
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-1597A

Cystatin C Kit (Immunoturbidimetric Assay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-1597A
Basic UDI-DI: B-1597A
Reference: /
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 08:47

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Calprotectin Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763730
Basic UDI-DI: B-15065023763730
Reference: TV20035
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-1-Antitrypsin (AAT) Assay Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-149H60TSC7W
Basic UDI-DI: B-149H60TSC7W
Reference: 149H60TSC
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-1-Antitrypsin (AAT) Assay Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-149H200TSCNK
Basic UDI-DI: B-149H200TSCNK
Reference: 149H200TSC
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-1-Acid Glycoprotein (AAG) Assay Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-147H60TSC6U
Basic UDI-DI: B-147H60TSC6U
Reference: 147H60TSC
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-1-Acid Glycoprotein (AAG) Assay Kit (Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-147H200TSCMD
Basic UDI-DI: B-147H200TSCMD
Reference: 147H200TSC
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 08:27

Manufacturer products Authorised representative products Authorised representative actors View details

14560189216133

CL AIA-PACK Presepsin ADJUSTER SET

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216133
Basic UDI-DI: B-14560189216133
Reference: 0029266
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

14560189216058

CL AIA-PACK Presepsin TEST CUP

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189216058
Basic UDI-DI: B-14560189216058
Reference: 0029166
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

14560189215976

CL AIA-PACK KL-6 ADJUSTER SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189215976
Basic UDI-DI: B-14560189215976
Reference: 0029258
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

14560189215969

CL AIA-PACK KL-6 TEST CUP

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189215969
Basic UDI-DI: B-14560189215969
Reference: 0029158
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details