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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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C-Reactive Protein/Serum Amyloid A (CRP/SAA) Test Kit (Immunofluorescence)

C-Reactive Protein/Serum Amyloid A (CRP/SAA) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482134
Basic UDI-DI: B-06978198482134
Reference: 2213
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer Test Kit (Immunofluorescence)

D-Dimer Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482127
Basic UDI-DI: B-06978198482127
Reference: 2212
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence)

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482110
Basic UDI-DI: B-06978198482110
Reference: 2211
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

High-sensitivity Cardiac Troponin I (Hs-cTnI) Test Kit (Immunofluorescence)

High-sensitivity Cardiac Troponin I (Hs-cTnI) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482103
Basic UDI-DI: B-06978198482103
Reference: 2210
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Creatine Kinase-MB / High-sensitivity Cardiac Troponin I / Myoglobin ( CK-MB/Hs-cTnI/Myo) Test Kit (Immunofluorescence)

Creatine Kinase-MB / High-sensitivity Cardiac Troponin I / Myoglobin ( CK-MB/Hs-cTnI/Myo) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482097
Basic UDI-DI: B-06978198482097
Reference: 2209
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

β-Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence)

β-Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482080
Basic UDI-DI: B-06978198482080
Reference: 2208
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Triiodothyronine (T3) Test Kit (Immunofluorescence)

Triiodothyronine (T3) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482073
Basic UDI-DI: B-06978198482073
Reference: 2207
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroxine (T4) Test Kit (Immunofluorescence)

Thyroxine (T4) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482066
Basic UDI-DI: B-06978198482066
Reference: 2206
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Free Triiodothyronine (FT3) Test Kit (Immunofluorescence)

Free Triiodothyronine (FT3) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482059
Basic UDI-DI: B-06978198482059
Reference: 2205
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroxine (FT4) Test Kit (Immunofluorescence)

Free Thyroxine (FT4) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482042
Basic UDI-DI: B-06978198482042
Reference: 2204
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence)

Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482035
Basic UDI-DI: B-06978198482035
Reference: 2203
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence)

25-OH Vitamin D (25-OH Vit-D) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482028
Basic UDI-DI: B-06978198482028
Reference: 2202
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)

Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000046524
UDI-DI: 06978198482011
Basic UDI-DI: B-06978198482011
Reference: 2201
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

4-plex F 100tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangxi CellGene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055358
UDI-DI: 06977846951428
Basic UDI-DI: B-06977846951428
Reference: E020600901 E020600902
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Control

3*3mL/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565586932
Basic UDI-DI: B-06977565586932
Reference: 6932
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

3*3mL/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565586833
Basic UDI-DI: B-06977565586833
Reference: 6832
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

3*1mL/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565586734
Basic UDI-DI: B-06977565586734
Reference: 6732
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Ag Control

3*1mL/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565586635
Basic UDI-DI: B-06977565586635
Reference: 6632
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

3*5mL/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565586536
Basic UDI-DI: B-06977565586536
Reference: 6532
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Control

3*1mL/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565586437
Basic UDI-DI: B-06977565586437
Reference: 6432
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 07.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details