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25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAI2022005HS
Basic UDI-DI: B-SAI2022005HS
Reference: SAI2022005
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:36

Manufacturer products View details

BeneCheck Total Cholesterol Control Solution

PD-F011

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F011ML
Basic UDI-DI: B-PD-F011ML
Reference: PD-F011
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Total Cholesterol Control Solution

PD-F010

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F010MJ
Basic UDI-DI: B-PD-F010MJ
Reference: PD-F010
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Uric Acid Control Solution

PD-F008

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F008MX
Basic UDI-DI: B-PD-F008MX
Reference: PD-F008
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Uric Acid Control Solution

PD-F007

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F007MV
Basic UDI-DI: B-PD-F007MV
Reference: PD-F007
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Uric Acid Control Solution

PD-F006

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

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F006MT
Basic UDI-DI: B-PD-F006MT
Reference: PD-F006
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Glucose Control Solution

PD-F005

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F005MR
Basic UDI-DI: B-PD-F005MR
Reference: PD-F005
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Glucose Control Solution

PD-F004

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F004MP
Basic UDI-DI: B-PD-F004MP
Reference: PD-F004
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

BeneCheck Glucose Control Solution

PD-F003

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-PD-F003MM
Basic UDI-DI: B-PD-F003MM
Reference: PD-F003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Brisa Blood Glucose Monitoring System

NM710

IVD Annex II List BIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-NM710WP
Basic UDI-DI: B-NM710WP
Reference: N710G01
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 05:23

Manufacturer products Authorised representative products Authorised representative actors View details

GREENCARE A1c Hemoglobin A1c Test Kit

GREENCARE A1c Hemoglobin A1c Test Kit

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: D-KR-MF-000015840BS
Basic UDI-DI: B-KR-MF-000015840BS
Reference: RT100S10
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Romania
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE Self Blood Uric Acid Test Strip

Blood Monitoring System

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786VUADX
Basic UDI-DI: B-KR-MF-000015786VUADX
Reference: 6417
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: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Self Triglyceride test strip

Blood Monitoring System

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786VTGE8
Basic UDI-DI: B-KR-MF-000015786VTGE8
Reference: 6136
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Self Total cholesterol test strip

Blood Monitoring System

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786VTCDY
Basic UDI-DI: B-KR-MF-000015786VTCDY
Reference: 6407
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Lipid test strip

QUCARE

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786PRLIPDJE
Basic UDI-DI: B-KR-MF-000015786PRLIPDJE
Reference: 6322/60A2
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Lipid test strip

Blood Monitoring System

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786LIPIDQ9
Basic UDI-DI: B-KR-MF-000015786LIPIDQ9
Reference: 6302
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Pro Hemoglobin test strip

QUCARE® Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786HBXU
Basic UDI-DI: B-KR-MF-000015786HBXU
Reference: 6092
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Denmark
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Pro Creatinine test strip

QUCARE® Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786CREAX
Basic UDI-DI: B-KR-MF-000015786CREAX
Reference: 6062
EMDN: W0101060112
EMDN description: CREATININE ANALYSIS TEST STRIPS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Pro Blood Urea Nitrogen test strip

QUCARE® Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786BUNBM
Basic UDI-DI: B-KR-MF-000015786BUNBM
Reference: 6052
EMDN: W0101060106
EMDN description: UREA TEST STRIPS
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Pro Blood Uric Acid test strip

QUCARE® Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786BUAAT
Basic UDI-DI: B-KR-MF-000015786BUAAT
Reference: 6032
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details