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Active filter:Manufacturer SRN:TW-MF-000027109

213 device results listed.

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BeneCheck Glucose Test Strip

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

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Glucose Test Strip

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

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Multi-Monitoring System

BK1-10M

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-10MEV
Basic UDI-DI: B-BK1-10MEV
Reference: BK1-10M
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

BeneCheck Multi-Monitoring System

BK1-10M-D3

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-10M-D3XR
Basic UDI-DI: B-BK1-10M-D3XR
Reference: BK1-10M-D3
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

BeneCheck Multi-Monitoring System

BK1-10M-D2

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-10M-D2XP
Basic UDI-DI: B-BK1-10M-D2XP
Reference: BK1-10M-D2
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

BeneCheck Multi-Monitoring System

BK1-10M-D1

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-10M-D1XM
Basic UDI-DI: B-BK1-10M-D1XM
Reference: BK1-10M-D1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

BeneCheck Multi-Monitoring System

BK1-10M-3

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-10M-3AF
Basic UDI-DI: B-BK1-10M-3AF
Reference: BK1-10M-3
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

BeneCheck Multi-Monitoring System

BK1-10M-2

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-10M-2AD
Basic UDI-DI: B-BK1-10M-2AD
Reference: BK1-10M-2
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

BeneCheck Multi-Monitoring System

BK1-10M-1

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK1-10M-1AB
Basic UDI-DI: B-BK1-10M-1AB
Reference: BK1-10M-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
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

BeneCheck Uric Acid Test Strip

BK-U1

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-U1TW
Basic UDI-DI: B-BK-U1TW
Reference: BK-U1
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
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

SANcheck ABEL β-Ketone Test Strip

BK-SK1

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-SK19S
Basic UDI-DI: B-BK-SK19S
Reference: BK-SK1
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE 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

BeneCheck Hb Hemoglobin Test Strip

BK-H2

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-H2SR
Basic UDI-DI: B-BK-H2SR
Reference: BK-H2
EMDN: W0103010601
EMDN description: HAEMOGLOBIN (HB)
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

BeneCheck Uric Acid Control Solution

BK-CSU12