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560 device results listed.

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PRIMA HOME TEST

800034-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-800034-1CS3S
Basic UDI-DI: B-800034-1CS3S
Reference: 800034-1CS
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST CRP

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-730000NK
Basic UDI-DI: B-730000NK
Reference: 730000
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:06

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

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

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

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

14560189213583

ST AIA-PACK KL-6

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189213583
Basic UDI-DI: B-14560189213583
Reference: 0025244
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

14560189213514

ST AIA-PACK Presepsin

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189213514
Basic UDI-DI: B-14560189213514
Reference: 0025242
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

VEUPLEX™ TBI assay

EZ-TBIV

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: EzDiaTech, Inc.
Manufacturer SRN: KR-MF-000026926
UDI-DI: 08809901510067
Basic UDI-DI: B-08809901510067
Reference: EZ-TBIV
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 10.07.2026 17:01

Manufacturer products Authorised representative products Authorised representative actors View details

08800037900852

SimplexTAS 101 CRP Reagent Cartridge

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: tascom co., ltd.
Manufacturer SRN: KR-MF-000019000
UDI-DI: 08800037900852
Basic UDI-DI: B-08800037900852
Reference: T0101022
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 00:06

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281511

Heparin binding protein Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281511
Basic UDI-DI: B-06979878281511
Reference: 1001045
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281504

Serum Amyloid A protein Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281504
Basic UDI-DI: B-06979878281504
Reference: 1001044
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281412

S100β Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281412
Basic UDI-DI: B-06979878281412
Reference: 1001035
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281375

Heart Type Fatty Acid Binding Protein Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281375
Basic UDI-DI: B-06979878281375
Reference: 1001031
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:51

Manufacturer products Authorised representative products Authorised representative actors View details

Vascular Endothelial Growth Factor Kit（CLIA）

100T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081337
Basic UDI-DI: B-06978945081337
Reference: CA1413B
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

Vascular Endothelial Growth Factor Kit（CLIA）

50T

IVD generalIVDDOn the marketKitReagent

Manufacturer: Jiangxi Medicalsystem Biological Technology Co., Ltd.
Manufacturer SRN: CN-MF-000050651
UDI-DI: 06978945081320
Basic UDI-DI: B-06978945081320
Reference: CA1413A
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details