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63 device results listed.

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RIGHTEST Brisa Plus Blood Glucose Monitoring System

NM712

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-NM712WT
Basic UDI-DI: B-NM712WT
Reference: N712G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
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

RIGHTEST Sol Plus Blood Glucose Monitoring System

NM702

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-NM702WQ
Basic UDI-DI: B-NM702WQ
Reference: N702G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
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

RIGHTEST Sol Blood Glucose Monitoring System

NM700

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-NM700WL
Basic UDI-DI: B-NM700WL
Reference: N700G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
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

Vaginal pH Rapid Test Panel

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVPH-504QA
Basic UDI-DI: B-IVPH-504QA
Reference: IVPH-504
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVPH-503Q8
Basic UDI-DI: B-IVPH-503Q8
Reference: IVPH-503
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 02:16

Manufacturer products Authorised representative products Authorised representative actors View details

Bionime Rightest GS300 Blood Glucose Test Strip

GS300

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GS300UV
Basic UDI-DI: B-GS300UV
Reference: 300G12
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
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

RIGHTEST Blood Glucose Monitoring System GM700SB

GM782

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM782V3
Basic UDI-DI: B-GM782V3
Reference: 782G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
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

RIGHTEST Blood Glucose Monitoring System GM700S

GM780

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM780UX
Basic UDI-DI: B-GM780UX
Reference: 780G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Mylife Unio Cara Blood Glucose Monitoring System

GM775

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM775V6
Basic UDI-DI: B-GM775V6
Reference: 775G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Max Blood Glucose Monitoring System

GM770

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM770UU
Basic UDI-DI: B-GM770UU
Reference: 770G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Blood Glucose Monitoring System GM700 Pro 2

GM762

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM762UV
Basic UDI-DI: B-GM762UV
Reference: 762G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Lithuania
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Rightest Blood Glucose Meter GM700 Pro

GM760

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM760UR
Basic UDI-DI: B-GM760UR
Reference: 760G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Lithuania
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

GE Blood Glucose Monitoring System GE200

GM750

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM750UN
Basic UDI-DI: B-GM750UN
Reference: 750G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

mylife Unio Neva Blood Glucose Monitoring System

GM722

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM722UH
Basic UDI-DI: B-GM722UH
Reference: 722G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Blood Glucose Monitoring System GM720

GM720

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM720UD
Basic UDI-DI: B-GM720UD
Reference: 720G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Blood Glucose Monitoring System GM700

GM700

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM700U7
Basic UDI-DI: B-GM700U7
Reference: 700G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Wiz Plus Blood Glucose Monitoring System

GM572

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM572UN
Basic UDI-DI: B-GM572UN
Reference: 572G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Wiz Blood Glucose Monitoring System

GM570

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM570UJ
Basic UDI-DI: B-GM570UJ
Reference: 570G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

GE Blood Glucose Monitoring System GE100

GM555

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM555UN
Basic UDI-DI: B-GM555UN
Reference: 555G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Greece
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Rightest Blood Glucose Monitoring System

GM550

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

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM550UC
Basic UDI-DI: B-GM550UC
Reference: 550G01
EMDN: W01010699
EMDN description: CLIN. CHEM. RT & POC - OTHER
First on market country: Slovakia
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details