Blood Glucose Test Strip

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Bionime Corporation·1 device

Lancing Device

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Bionime Corporation·1 device

Lancing Device

Basic UDI-DI

EU MDD · Eu Md Class 1 ·Bionime Corporation·1 device

Mobile Application For Blood Glucose Monitoring System

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·Bionime Corporation·1 device

HL 2110160-1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Bionime Corporation·TÜV Rheinland LGA Products GmbH·36 Basic UDI-DIs

Bionime Corporation

System producer

🇹🇼 Taiwan

BIOSEVEN SRL

Authorized representative

🇮🇹 Italy·1 Manufacturer·39 Devices

Diamedics, s.r.o.

Importer

🇨🇿 Czechia·1 Manufacturer

HUNGIMPEX Kft.

Importer

🇭🇺 Hungary·1 Manufacturer

KARABINIS MEDICAL S.A.

Importer

1 Manufacturer

ILINE MICROSYSTEMS S.L.

Importer

🇪🇸 Spain·1 Manufacturer

Salvus društvo s ograničenom odgovornošću za trgovinu i usluge

Importer

🇭🇷 Croatia·1 Manufacturer

BIOSEVEN SRL

Importer

🇮🇹 Italy·1 Manufacturer

STADAPHARM GmbH

Importer

🇩🇪 Germany·1 Manufacturer

Ypsomed Distribution GmbH

Importer

🇩🇪 Germany·2 Manufacturers

A-MED, s.r.o.

Importer

🇸🇰 Slovakia·3 Manufacturers

Interlux, UAB

Importer

🇱🇹 Lithuania·3 Manufacturers

BIOGINE FARMA, SLU

Importer

🇪🇸 Spain·4 Manufacturers

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry