Clip, Nose

FDA classification

FDA Class 1 ·Clip, Nose

Determine HIV Early Detect

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

EDTA Capillary Tubes

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Determine HIV Controls

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Chase Buffer

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Synthon auto-injector (brand names:MyJect, Autoxon, Perscleran, Sensigo)

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Synthon Hispania S.L.·2 devices

Abbott Rapid Dx International Limited

Importer

🇮🇪 Ireland·11 Manufacturers

Inflation Device

Basic UDI-DI

EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·2 devices

Care Surgical Supplies Limited

Authorized representative

🇮🇪 Ireland·2 Manufacturers·371 Devices

ITENA CLINICAL

Importer

🇫🇷 France·10 Manufacturers

Abbott Rapid Dx International Limited

Authorized representative

🇮🇪 Ireland·5 Manufacturers·4 Devices

V7 103108 0005

Certificate

IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

V7 103108 0007

Certificate

IVDD Annex IV Section 4·Abbott Diagnostics Medical Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

AKRALAB S.L.U.

Importer

🇪🇸 Spain·8 Manufacturers

MediMark Europe Sarl.

Authorized representative

🇫🇷 France·35 Manufacturers·3394 Devices

JaviTech e.K.

Authorized representative

🇩🇪 Germany·111 Manufacturers·1816 Devices

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

Luxus Lebenswelt GmbH

Authorized representative

🇩🇪 Germany·191 Manufacturers·2068 Devices

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

Wellkang Ltd

Authorized representative

259 Manufacturers·3500 Devices