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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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01.08.2026 18:27

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MINICAP Hb A1c

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: sebia
Manufacturer SRN: FR-MF-000003520
UDI-DI: 03607360022153
Basic UDI-DI: 3607362215BUBY
Reference: 2215
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:08

Manufacturer products View details

CAPILLARYS Hb A1c

CAPILLARYS Hb A1c

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: sebia
Manufacturer SRN: FR-MF-000003520
UDI-DI: 03607360020159
Basic UDI-DI: 3607362015BUBA
Reference: 2015
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:07

Manufacturer products View details

Access Substrate

81906

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590229986
Basic UDI-DI: 150995901AccSubstrateHR
Reference: 81906
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems ALB Albumin Reagent

IMMAGE Immunochemistry Systems ALB Albumin Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590221201
Basic UDI-DI: 150995901447600L3
Reference: 447600
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents for STAT LAB T Analyzer & Auto Chemistry Analyzer HbA1c kit

401 002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041047324
Basic UDI-DI: B-62230041047324
Reference: 401 002
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Direct Bilirubin DPD

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873011037
Basic UDI-DI: B-84352873011037
Reference: KR10082
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:25

Manufacturer products View details

Direct Bilirubin DPD

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873011020
Basic UDI-DI: B-84352873011020
Reference: CT10085
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:25

Manufacturer products View details

Direct Bilirubin DPD

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873011013
Basic UDI-DI: B-84352873011013
Reference: CT10082
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:25

Manufacturer products View details

Direct Bilirubin DPD

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873011006
Basic UDI-DI: B-84352873011006
Reference: CT10080
EMDN: W01010203
EMDN description: BILIRUBIN
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:25

Manufacturer products View details

Glucose (GLU) Test Kit (Hexokinase)

R1:20mL×4 R2:5mL×4（796）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306368
Basic UDI-DI: B-06936895306368
Reference: R1:20mL×4 R2:5mL×4（796）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:20mL×4 R2:5mL×4（707）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306344
Basic UDI-DI: B-06936895306344
Reference: R1:20mL×4 R2:5mL×4（707）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:20mL×4 R2:5mL×4（710）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306351
Basic UDI-DI: B-06936895306351
Reference: R1:20mL×4 R2:5mL×4（710）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:50ml×2 R2:25ml×1（793）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306337
Basic UDI-DI: B-06936895306337
Reference: R1:50ml×2 R2:25ml×1（793）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:48ml×2 R2:24ml×1（792）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306320
Basic UDI-DI: B-06936895306320
Reference: R1:48ml×2 R2:24ml×1（792）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:48ml×2 R2:24ml×1（791）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306313
Basic UDI-DI: B-06936895306313
Reference: R1:48ml×2 R2:24ml×1（791）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:64mL×2 R2:16mL×2（794）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306306
Basic UDI-DI: B-06936895306306
Reference: R1:64mL×2 R2:16mL×2（794）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:100ml×1 R2:25ml×1（708）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306290
Basic UDI-DI: B-06936895306290
Reference: R1:100ml×1 R2:25ml×1（708）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:80ml×2 R2:20ml×2（706）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306283
Basic UDI-DI: B-06936895306283
Reference: R1:80ml×2 R2:20ml×2（706）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:48mL×2 R2:12mL×2（798）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306276
Basic UDI-DI: B-06936895306276
Reference: R1:48mL×2 R2:12mL×2（798）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Glucose (GLU) Test Kit (Hexokinase)

R1:48mL×2 R2:12mL×2（716）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895306269
Basic UDI-DI: B-06936895306269
Reference: R1:48mL×2 R2:12mL×2（716）
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 29.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details