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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 16:25

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104 device results listed.

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Glycated Hemoglobin A1c Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2593002E3
Basic UDI-DI: B-BL2593002E3
Reference: BL2593002
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2593001DZ
Basic UDI-DI: B-BL2593001DZ
Reference: BL2593001
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:28

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2592001DS
Basic UDI-DI: B-BL2592001DS
Reference: BL2592001
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2591002DM
Basic UDI-DI: B-BL2591002DM
Reference: BL2591002
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin A1c Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-BL2591001DK
Basic UDI-DI: B-BL2591001DK
Reference: BL2591001
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

spinit® HbA1c control

IVD generalIVDDOn the marketHuman tissuesNear-patient testingProfessional testingReagent

Manufacturer: biosurfit SA
Manufacturer SRN: PT-MF-000033920
UDI-DI: D-910301P8
Basic UDI-DI: B-910301P8
Reference: 910301
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Portugal
Authorised representative: -
Last updated: 12.07.2026 20:55

Manufacturer products View details

HbA1c, Lyophilised hemolysate Level 3

HbA1c, Lyophilised hemolysate

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Streekziekenhuis Koningin Beatrix
Manufacturer SRN: NL-MF-000000427
UDI-DI: 87205897081050
Basic UDI-DI: B-87205897081050
Reference: HBA-01.3_011
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Netherlands
Authorised representative: -
Last updated: 12.07.2026 20:22

Manufacturer products View details

Z-Hb Confirm HbA1c Control Kit

Z-Hb Confirm HbA1c Control Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: ZOVEC diagnostics GmbH
Manufacturer SRN: DE-MF-000035393
UDI-DI: 42625753901600
Basic UDI-DI: B-42625753901600
Reference: Z-RHBQC
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:42

Manufacturer products View details

Seronorm® HbA1c Liquid L-2

Seronorm® HbA1c Liquid L-2

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: SERO AS
Manufacturer SRN: NO-MF-000012954
UDI-DI: 17090041920542
Basic UDI-DI: B-17090041920542
Reference: 209105
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Norway
Authorised representative: -
Last updated: 11.07.2026 10:11

Manufacturer products View details

Seronorm® HbA1c Liquid L-1

Seronorm® HbA1c Liquid L-1

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: SERO AS
Manufacturer SRN: NO-MF-000012954
UDI-DI: 17090041920535
Basic UDI-DI: B-17090041920535
Reference: 209005
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Norway
Authorised representative: -
Last updated: 11.07.2026 10:11

Manufacturer products View details

extendSURE™ HbA1c Liquid Controls

B12397

IVD generalIVDDOn the marketHuman tissuesKit

Manufacturer: Canterbury Scientific Limited
Manufacturer SRN: NZ-MF-000001778
UDI-DI: 09421902348099
Basic UDI-DI: B-09421902348099
Reference: B12397
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 10.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

extendSURETM Haemoglobin A1c Lyophilised Controls

HB710SBAr

IVD generalIVDDOn the marketHuman tissuesKit

Manufacturer: Canterbury Scientific Limited
Manufacturer SRN: NZ-MF-000001778
UDI-DI: 09421902348075
Basic UDI-DI: B-09421902348075
Reference: HB710SBAr
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 10.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

extendSURE™ HbA1c Liquid Controls

B12396

IVD generalIVDDOn the marketHuman tissuesKit

Manufacturer: Canterbury Scientific Limited
Manufacturer SRN: NZ-MF-000001778
UDI-DI: 09421902348006
Basic UDI-DI: B-09421902348006
Reference: B12396
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 10.07.2026 23:51

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 3 in 1 GHL Glucose Control Solution

M 400

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065181001
Basic UDI-DI: B-08800065181001
Reference: M400C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-STAT™ HbA1c Control Solution

CS 4000

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagent

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065178001
Basic UDI-DI: B-08800065178001
Reference: CS400C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-STAT™ 2000 HbA1c Control Solution

CS 2000

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065176007
Basic UDI-DI: B-08800065176007
Reference: CS200C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 1Code Glucose Control Solution

G 400

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065174003
Basic UDI-DI: B-08800065174003
Reference: G400C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

CERA-CHEK™ 1070 Glucose Control Solution

G 300

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065172009
Basic UDI-DI: B-08800065172009
Reference: G300C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

LabonaCheck™ A1c Control Solution

MH 200

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testing

Manufacturer: GC MEDIS Corp.
Manufacturer SRN: KR-MF-000012638
UDI-DI: 08800065168002
Basic UDI-DI: B-08800065168002
Reference: MH200C10
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 05:12

Manufacturer products Authorised representative products Authorised representative actors View details

HBA1C KONTROL SET

HBA1C CONTROL SET

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000027166
UDI-DI: 08699015281829
Basic UDI-DI: B-08699015281829
Reference: 01R96-01
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 16:12

Manufacturer products View details