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195 device results listed.

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GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-103715M9
Basic UDI-DI: B-103715M9
Reference: 103715
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

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GLUCOCARD W Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-103714M7
Basic UDI-DI: B-103714M7
Reference: 103714
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

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GLUCOCARD S Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102634LZ
Basic UDI-DI: B-102634LZ
Reference: 102634
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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GLUCOCARD S Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102633LX
Basic UDI-DI: B-102633LX
Reference: 102633
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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GLUCOCARD S Control Solution

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102632LV
Basic UDI-DI: B-102632LV
Reference: 102632
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Croatia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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GLUCOCARD SM CONTROL

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102526LV
Basic UDI-DI: B-102526LV
Reference: 102526
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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GLUCOCARD SM CONTROL

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102525LT
Basic UDI-DI: B-102525LT
Reference: 102525
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:57

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08809446081589

HCA-N05082

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446081589
Basic UDI-DI: B-08809446081589
Reference: HCA-N05082
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 10.07.2026 14:10

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ELEMENT Blood Glucose Control Solution (High)

INFCH21APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115909633
Basic UDI-DI: B-08809115909633
Reference: INFCH21APT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Control Solution (High)

INFC21A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908827
Basic UDI-DI: B-08809115908827
Reference: INFC21A
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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ELEMENT Blood Glucose Control Solution (Low)

INFC21A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908810
Basic UDI-DI: B-08809115908810
Reference: INFC21A
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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ELEMENT Blood Glucose Control Solution (Normal)

INFC21A

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908803
Basic UDI-DI: B-08809115908803
Reference: INFC21A
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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EXADEMIN® Fast Blood Glucose Control Solution (High, Low)

INFS003APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908278
Basic UDI-DI: B-08809115908278
Reference: INFS003APT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

ELEMENT Blood Glucose Control Solution (Low)

INFCL21APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908636
Basic UDI-DI: B-08809115908636
Reference: INFCL21APT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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EXADEMIN® Fast Blood Glucose Control Solution (Normal)

INFM003APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908261
Basic UDI-DI: B-08809115908261
Reference: INFM003APT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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GluNEO plus Blood Glucose Control Solution (High)

INFCL003APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908230
Basic UDI-DI: B-08809115908230
Reference: INFCL003APT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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Oh'Care Lite Blood Glucose Control Solution (Normal)

INFS001LSK

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907417
Basic UDI-DI: B-08809115907417
Reference: INFS001LSK
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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Oh'Care Lite Blood Glucose Control Solution (Low)

INFM001LSK

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907400
Basic UDI-DI: B-08809115907400
Reference: INFM001LSK
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

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Oh'Care Lite Blood Glucose Control Solution (High)

INFM001LBG

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115905956
Basic UDI-DI: B-08809115905956
Reference: INFM001LBG
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

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ELEMENT Blood Glucose Control Solution (Normal)

INFCH21APT

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115904638
Basic UDI-DI: B-08809115904638
Reference: INFCN21APT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details