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

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22.09.2026 20:14

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312 device results listed.

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08435287147667

LKM POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287147667
Basic UDI-DI: B-08435287147667
Reference: 44766
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287146967

NEGATIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287146967
Basic UDI-DI: B-08435287146967
Reference: 44696
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:49

Manufacturer products View details

08435287145427

nDNA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145427
Basic UDI-DI: B-08435287145427
Reference: 44542
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287135039

SEROLOGY NEGATIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287135039
Basic UDI-DI: B-08435287135039
Reference: 33503
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287106190

nDNA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287106190
Basic UDI-DI: B-08435287106190
Reference: 44894
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:42

Manufacturer products View details

08012992503867

LKM POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503867
Basic UDI-DI: B-08012992503867
Reference: 50386
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:46

Manufacturer products View details

08012992503706

NEGATIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503706
Basic UDI-DI: B-08012992503706
Reference: 50370
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

Manufacturer products View details

08012992503676

nDNA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503676
Basic UDI-DI: B-08012992503676
Reference: 50367
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

Manufacturer products View details

Mercodia Diabetes Antigen Control (Low, High) / Human

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Mercodia AB
Manufacturer SRN: SE-MF-000005175
UDI-DI: 07350108630160
Basic UDI-DI: B-07350108630160
Reference: 10-1164-01
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:17

Manufacturer products View details

06978896416219

C1: 1*1 mL C2: 1*1 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416219
Basic UDI-DI: B-06978896416219
Reference: W-C-Lp-PLA2-1
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

06978896416103

C1: 1*1 mL C2: 1*1 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896416103
Basic UDI-DI: B-06978896416103
Reference: W-C-DEN-1
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:50

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control

C1: 1*1 mL C2: 1*1 mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896415328
Basic UDI-DI: B-06978896415328
Reference: W-C-HbA1c-1
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin D Control

C1: 1*1 mL C2: 1*1 mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896415311
Basic UDI-DI: B-06978896415311
Reference: W-C-VD-1
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

iFOB Control

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

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

HbA1c Control

6*0.5mL/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Coei Biotech Co.Ltd.
Manufacturer SRN: CN-MF-000049509
UDI-DI: 06977565586031
Basic UDI-DI: B-06977565586031
Reference: 6032
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

Fluorescence Immunoassay Quality Control Kit

YH-QC120

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490831
Basic UDI-DI: B-06975679490831
Reference: YH-QC120
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:42

Manufacturer products Authorised representative products Authorised representative actors View details

Biochemical Quality Control Kit

YH-QC130

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Ehome Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045177
UDI-DI: 06975679490824
Basic UDI-DI: B-06975679490824
Reference: YH-QC130
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Calprotectin Quality Control (Quantitative)

FC-QC-3

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361931
Basic UDI-DI: B-06974735361931
Reference: FC-QC-3
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details