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ZuhauseTEST PSA

IVD Annex II List BIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-720000N8
Basic UDI-DI: B-720000N8
Reference: 720000
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOCARD SM TEST STRIPS

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47395HX
Basic UDI-DI: B-47395HX
Reference: 47395
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

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GLUCOCARD SM TEST STRIPS

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47393HT
Basic UDI-DI: B-47393HT
Reference: 47393
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

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GLUCOCARD SM TEST STRIPS

IVD Annex II List BIVDDNo longer on the marketReagentSelf testing

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: D-47389J4
Basic UDI-DI: B-47389J4
Reference: 47389
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

GDH Glucose control solution

GDH

IVD self-testing devicesIVDDOn the marketReagentSelf testing

Manufacturer: Leison Biotech Co., Ltd.
Manufacturer SRN: TW-MF-000026417
UDI-DI: D-471987421CSYDLT
Basic UDI-DI: B-471987421CSYDLT
Reference: N/A
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 19:57

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AP-10

IVD self-testing devicesIVDDOn the marketReagentSelf testingSingle use

Manufacturer: Leison Biotech Co., Ltd.
Manufacturer SRN: TW-MF-000026417
UDI-DI: D-471987421AP-10STRIPE3SZ
Basic UDI-DI: B-471987421AP-10STRIPE3SZ
Reference: N/A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 19:57

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AP-10

IVD self-testing devicesIVDDOn the marketInstrumentKitReagentSelf testingSingle use

Manufacturer: Leison Biotech Co., Ltd.
Manufacturer SRN: TW-MF-000026417
UDI-DI: D-471987421AP-108W8C
Basic UDI-DI: B-471987421AP-108W8C
Reference: N/A
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 19:57

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GlucoSure Star

GlucoSure Star Blood Glucose Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487699A08Q
Basic UDI-DI: B-47136487699A08Q
Reference: S70304, S70052, S70005, S70008
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

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GlucoSure Star

GlucoSure Star Blood Glucose Test Strips

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487699ATAW
Basic UDI-DI: B-47136487699ATAW
Reference: S5636026, S5636046, S5636053, S5636084, S5636094
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Contrex Plus

Contrex Plus glucose control solution

IVD Annex II List BIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487699ASAU
Basic UDI-DI: B-47136487699ASAU
Reference: S5800012
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Uric Acid Test Strip

IVD self-testing devicesIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613AUT3C
Basic UDI-DI: B-47136487613AUT3C
Reference: S5640832 S5640833
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Uric Acid Control Solution

IVD self-testing devicesIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613AUS3A
Basic UDI-DI: B-47136487613AUS3A
Reference: S5800343 S5800346
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Triglyceride Test Strip

IVD self-testing devicesIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ATT39
Basic UDI-DI: B-47136487613ATT39
Reference: S5640823 S5640821 S5640822 S5640824
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

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MultiSure

MultiSure Triglyceride Control Solution

IVD self-testing devicesIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ATS37
Basic UDI-DI: B-47136487613ATS37
Reference: S5800342
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Blood Glucose Test Strip

IVD Annex II List BIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613AT88
Basic UDI-DI: B-47136487613AT88
Reference: S5640432 S5640437 S5640439 S5640431
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Cholesterol Test Strip

IVD self-testing devicesIVDDNo longer on the marketMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ACTZK
Basic UDI-DI: B-47136487613ACTZK
Reference: S5640826 S5640829 S5640825 S5640827 S5640831 S5640828 S5640830
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure

MultiSure Cholesterol Control Solution

IVD self-testing devicesIVDDNo longer on the marketNear-patient testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613ACSZH
Basic UDI-DI: B-47136487613ACSZH
Reference: S5800344 S5800345
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GCTU

MultiSure GCTU Monitoring System

IVD Annex II List BIVDDNo longer on the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487613A062
Basic UDI-DI: B-47136487613A062
Reference: S81001, S81002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GK

MultiSure GK blood glucose test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487612AT83
Basic UDI-DI: B-47136487612AT83
Reference: S5640624, S5640451, S5640452
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MultiSure GK

MultiSure GK glucose control solution

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487612AS7Z
Basic UDI-DI: B-47136487612AS7Z
Reference: S5800192
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details