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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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adia Blood Glucose Control Solution (Low)

21415

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110165
Basic UDI-DI: B-04260235110165
Reference: 21415
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Test Strip

21467

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110325
Basic UDI-DI: B-04260235110325
Reference: 21467
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Test Strip

21416

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110172
Basic UDI-DI: B-04260235110172
Reference: 21416
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Control Solution (Normal)

21414

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110158
Basic UDI-DI: B-04260235110158
Reference: 21414
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO plus Blood Glucose Control Solution (High)

INFM003KG

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260072576506
Basic UDI-DI: B-04260072576506
Reference: INFM003KG
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:48

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCO TEST Plus Blutzuckerteststreifen 50 St.

Blood Glucose Test Strip

IVD Annex II List BIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04251575910188
Basic UDI-DI: B-04251575910188
Reference: TD-4304
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 07:47

Manufacturer products Authorised representative products Authorised representative actors View details

VOX Blood Glucose Test Strips

OK3I

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testingSingle use

Manufacturer: OK biotech co., Ltd
Manufacturer SRN: TW-MF-000028031
UDI-DI: 03760164730249
Basic UDI-DI: B-03760164730249
Reference: OK3I
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 05.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Direct Bilirubin/Total Protein/Alkaline Phosphatase/Glutamyl Transferase Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0013YJ
Basic UDI-DI: B-02B0013YJ
Reference: 1G001
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

SPUG

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0212YD
Basic UDI-DI: B-01B0212YD
Reference: 4B003
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ UG

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0206YJ
Basic UDI-DI: B-01B0206YJ
Reference: 1V003
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

SPUG

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0112Y8
Basic UDI-DI: B-01B0112Y8
Reference: 4B002
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ maxⅡ, Safe AQ max Ⅲ

IVD self-testing devicesIVDDOn the marketNear-patient testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0111Y6
Basic UDI-DI: B-01B0111Y6
Reference: 5Y002, 5Z002, 6A002, 6B002, 6B003, 6C001, 6C002, 6C003, 6C004, 6C005, 6C006, 6C007, 6D004, 6D005, 6D006
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ UG

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0106YD
Basic UDI-DI: B-01B0106YD
Reference: 1V002
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0104Y9
Basic UDI-DI: B-01B0104Y9
Reference: 2J002
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ Angel

IVD self-testing devicesIVDDOn the marketNear-patient testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0103Y7
Basic UDI-DI: B-01B0103Y7
Reference: 2B002
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe-Accu 2

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0102Y5
Basic UDI-DI: B-01B0102Y5
Reference: 5D002
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe-Accu

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0101Y3
Basic UDI-DI: B-01B0101Y3
Reference: 1N003
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ Voice; Safe AQ Smart; Safe AQ Air

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0104XW
Basic UDI-DI: B-01A0104XW
Reference: 2J003; 2J004; 2K002; 2K003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe AQ Angel

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0103XU
Basic UDI-DI: B-01A0103XU
Reference: 2B001
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

Safe-Accu 2

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01A0102XS
Basic UDI-DI: B-01A0102XS
Reference: 5D001
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details