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439 device results listed.

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GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-104861MU
Basic UDI-DI: B-104861MU
Reference: 104861
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S onyx (GT-7120)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-104166M3
Basic UDI-DI: B-104166M3
Reference: 104166
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Czechia
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD SM (GT-7120)

IVD Annex II List BIVDDNo longer on the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-102023KW
Basic UDI-DI: B-102023KW
Reference: 102023
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-101953MD
Basic UDI-DI: B-101953MD
Reference: 101953
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Lithuania
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:56

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W (GT-7210)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100820LJ
Basic UDI-DI: B-100820LJ
Reference: 100820
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W (GT-7210)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100819LZ
Basic UDI-DI: B-100819LZ
Reference: 100819
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W (GT-7210)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100818LX
Basic UDI-DI: B-100818LX
Reference: 100818
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD W (GT-7210)

IVD Annex II List BIVDDOn the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100816LT
Basic UDI-DI: B-100816LT
Reference: 100816
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Ireland
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100806LQ
Basic UDI-DI: B-100806LQ
Reference: 100806
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD S (GT-7110)

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100810LF
Basic UDI-DI: B-100810LF
Reference: 100810
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: France
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100477LT
Basic UDI-DI: B-100477LT
Reference: 100477
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100476LR
Basic UDI-DI: B-100476LR
Reference: 100476
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD X-mini plus (GT-1960)

IVD Annex II List BIVDDNo longer on the marketInstrumentKitReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-100475LP
Basic UDI-DI: B-100475LP
Reference: 100475
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Gmate® Blood Glucose Test Strips

PS-004

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testingSingle use

Manufacturer: GB Lifecare Co., Ltd.
Manufacturer SRN: KR-MF-000039508
UDI-DI: 08809301168486
Basic UDI-DI: B-08809301168486
Reference: PS004-INT
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 13:39

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFM001ASK

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908780
Basic UDI-DI: B-08809115908780
Reference: INFM001ASK
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Slovakia
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 Monitoring System for self-testing

INFM21APT

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908377
Basic UDI-DI: B-08809115908377
Reference: INFM21APT
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
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

FINETEST Auto-coding premium Blood Glucose Monitoring System for self-testing

INFM16B

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908520
Basic UDI-DI: B-08809115908520
Reference: INFM16B
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Croatia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO plus Blood Glucose Monitoring System for self-testing

INFCN003APT

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115908247
Basic UDI-DI: B-08809115908247
Reference: INFCN003APT
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
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

GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFM22ASV

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907561
Basic UDI-DI: B-08809115907561
Reference: INFM22ASV
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Slovenia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 12:00

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOLAB Auto-Coding Blood Glucose Monitoring System for self-testing

INFS22ARU

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08809115907066
Basic UDI-DI: B-08809115907066
Reference: INFS22ARU
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 11:59

Manufacturer products Authorised representative products Authorised representative actors View details