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UltraCE Serum Protein

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025689
Basic UDI-DI: 505601300ULTCESPE6
Reference: V8100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-MX SP-10 Kit

Serum Protein Kits

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013007944
Basic UDI-DI: 5056013005BANDM8
Reference: 100100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Alpha-1-Microglobulin Urine Control Pack

NK036.U.OPT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700019361
Basic UDI-DI: 5051700NK036.U.OPTQM
Reference: NQ036.U.OPT
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Alpha-2-Macroglobulin Urine Control Pack

NK039.U.OPT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700019354
Basic UDI-DI: 5051700NK039.U.OPTS8
Reference: NQ039.U.OPT
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

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Optilite® Alpha-2-Macroglobulin Kit

NK039.OPT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017442
Basic UDI-DI: 5051700NK039.OPT7S
Reference: NK039.OPT
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Optilite® Cystatin C Kit

LK048.OPT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017220
Basic UDI-DI: 5051700LK048.OPT6E
Reference: LK048.OPT
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:04

Manufacturer products Authorised representative products Authorised representative actors View details

α1-Microglobulin

a1-Microglobulin

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Denka Co., Ltd.
Manufacturer SRN: JP-MF-000015952
UDI-DI: 04987503610119
Basic UDI-DI: 4987503A1MGUWK
Reference: 08944539190
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

NESCAUTO Cp Auto AA01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274126826
Basic UDI-DI: 4987274W0102019009CPR02ZR
Reference: 912682
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

NESCAUTO Cp Auto NS-Prime

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274126819
Basic UDI-DI: 4987274W0102019009CPR01ZP
Reference: 912681
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

DNlite-IVD103

DNlite uPTM-FetA ELISA Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879490664
Basic UDI-DI: 471987949E103017J
Reference: 8103106 (4oC)
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

DNlite-IVD103

DNlite uPTM-FetA ELISA Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879490053
Basic UDI-DI: 471987949E103017J
Reference: 8103106 (-20oC)
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

OROSOMUCOID IP

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700823100
Basic UDI-DI: 37017008IORO03DD
Reference: IORO-0400
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:51

Manufacturer products View details

IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224066
Basic UDI-DI: 150995901447780LY
Reference: 447780
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224059
Basic UDI-DI: 150995901447790M3
Reference: 447790
EMDN: W0102019003
EMDN description: A2-MACROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224042
Basic UDI-DI: 150995901447740LL
Reference: 447740
EMDN: W0102019002
EMDN description: A1-ANTITRYPSIN (PROTEASE INHIBITOR)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224028
Basic UDI-DI: 150995901447750LP
Reference: 447750
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590180140
Basic UDI-DI: 150995901447710LB
Reference: 447710
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:31

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Latex

OSR6299

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590020392
Basic UDI-DI: 150995901OSR6299N5
Reference: OSR6299
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin

OSR61203

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590011901
Basic UDI-DI: 150995901OSR61203SK
Reference: OSR61203
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Latex

OSR6199

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010959
Basic UDI-DI: 150995901OSR6199MY
Reference: OSR6199
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details