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EUDAMED Device Search

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QUCARE® Pro beta-hydroxybutyrate test strip

QUCARE® Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786BHB9N
Basic UDI-DI: B-KR-MF-000015786BHB9N
Reference: 6022
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE 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

On Call Blood Uric Acid Test Strips

OGS-201

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-GU134-11DKX
Basic UDI-DI: B-GU134-11DKX
Reference: GU134-11D
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Blood Uric Acid Test Strips

OGS-201

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-GU134-10DKU
Basic UDI-DI: B-GU134-10DKU
Reference: GU134-10D
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Uric Acid Control Solution

OGC-201

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

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: D-GU124-12DKM
Basic UDI-DI: B-GU124-12DKM
Reference: GU124-12D
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Bionime Rightest Max Blood Glucose Test Strip

GS770

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GS770W6
Basic UDI-DI: B-GS770W6
Reference: 770G
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

Bionime Rightest GS100 Blood Glucose Test Strip

GS100

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GS100UK
Basic UDI-DI: B-GS100UK
Reference: 100G12
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:43

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System

GM771

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM771UW
Basic UDI-DI: B-GM771UW
Reference: 771K01
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

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RIGHTEST ALPHA Blood Glucose Monitoring System

GM551

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM551UE
Basic UDI-DI: B-GM551UE
Reference: 551G01
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Croatia
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

On Call Sure Blood Glucose Test Strips

OGS-211