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Manufacturer products Authorised representative products Authorised representative actors View details

BK6-G

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK6-GSY
Basic UDI-DI: B-BK6-GSY
Reference: BK6-G
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:26

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BK3-G

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK3-GSH
Basic UDI-DI: B-BK3-GSH
Reference: BK3-G
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:26

Manufacturer products Authorised representative products Authorised representative actors View details

BK3-G2

IVD Annex II List BIVDDNo longer on the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK3-G24Z
Basic UDI-DI: B-BK3-G24Z
Reference: BK3-G2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:26

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BK3-G1

IVD Annex II List BIVDDNo longer on the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK3-G14X
Basic UDI-DI: B-BK3-G14X
Reference: BK3-G1
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:26

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BK1-G

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-GS7
Basic UDI-DI: B-BK1-GS7
Reference: BK1-G
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:26

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BK1-G3

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-G34M
Basic UDI-DI: B-BK1-G34M
Reference: BK1-G3
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:26

BeneCheck Supreme Glucose Test Strip

BK-SG1

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-SG19E
Basic UDI-DI: B-BK-SG19E
Reference: BK-SG1
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

EASYGLUCO Auto-coding Blood Glucose Test Strip

INFS22AIT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: A938796036
Basic UDI-DI: B-A938796036
Reference: INFS22AIT
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 12.07.2026 21:11

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EASYGLUCO Auto-coding Blood Glucose Test Strip

INFSS22AIT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: A938795921
Basic UDI-DI: B-A938795921
Reference: INFSS22AIT
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 12.07.2026 21:11

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CareBuddy

CFU-GS1

IVD self-testing devicesIVDDOn the marketCompanion diagnosticsHuman tissuesKitNear-patient testingReagentSelf testingSingle use

Manufacturer: CareforU.Co.Ltd
Manufacturer SRN: KR-MF-000031539
UDI-DI: D-8800210900006UK
Basic UDI-DI: B-8800210900006UK
Reference: CGSB02
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Iceland
Authorised representative: Meridius Medical Europe Limited
Last updated: 12.07.2026 20:26

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GlucoMen areo Sensor

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

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSSgluEJS6
Basic UDI-DI: B-8012992BGMSSgluEJS6
Reference: 46182,46181,46184,46183,46192,46193,46191,46190,46189,46188,47948,48702,48704,48705,48706,48526, 48527,48528,48529,49198
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: -
Last updated: 12.07.2026 09:30

GLUCOFIX TECH Sensor

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

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSSgluEJ2M4
Basic UDI-DI: B-8012992BGMSSgluEJ2M4
Reference: 46627 NL, 46626, 46623 FR, 46622 FR10,47688 FR 50, 48587 IT, 48586 IT10, 48585 IT25, 48584 IT, 51342 UK, 51343 UK
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: -
Last updated: 12.07.2026 09:30

GlucoMen areo GK

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

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSMgluketUVRW
Basic UDI-DI: B-8012992BGMSMgluketUVRW
Reference: 54524, 52082, 52081, 52083, 61554, 61553,
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Belgium
Authorised representative: -
Last updated: 12.07.2026 09:30

GlucoMen areo

GlucoMen areo Set

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

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSMgluD8NK
Basic UDI-DI: B-8012992BGMSMgluD8NK
Reference: 46203, 46211,46210, 46213, 49261, 48742, 46214, 46215, 46212
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Belgium
Authorised representative: -
Last updated: 12.07.2026 09:30

Agamatrix Jazz Test Strips

800003712

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

Manufacturer: AgaMatrix, Inc.
Manufacturer SRN: US-MF-000039145
UDI-DI: D-800003712JG
Basic UDI-DI: B-800003712JG
Reference: 800003712
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Northern Ireland
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 09:29

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Manufacturer products Authorised representative products Authorised representative actors View details

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78730JX
Basic UDI-DI: B-78730JX
Reference: 78730
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78728KC
Basic UDI-DI: B-78728KC
Reference: 78728
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-78727KA
Basic UDI-DI: B-78727KA
Reference: 78727
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 12.07.2026 09:26