RFX+CARE Manufacturing Co., Ltd.

System producer

🇨🇳 China

Radiation Attenuating Medical Glove

FDA classification

FDA Class 1 ·Radiation Attenuating Medical Glove

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protego TD 75/18, 65/18, 65/16; T 65; SD 75/18, 65/18, 65/16, 60/16, S75, S65, S60; Protego DF-1 TD 75/18, 65/18, 65/16;

Eurolink Europe Compliance Limited

Authorized representative

🇮🇪 Ireland·35 Manufacturers·252 Devices

Laboratoires URGO Healthcare

Importer

🇫🇷 France·8 Manufacturers

X SERIES MONITOR/DEFIBRILLATOR

FDA UDI

Zoll Medical Corporation·00847946045470·X SERIES MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2,...

NATECH

Importer

🇫🇷 France·11 Manufacturers

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

Dayes Europe B.V.

Importer

🇳🇱 Netherlands·8 Manufacturers

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

BIOSYNEX

Importer

🇫🇷 France·19 Manufacturers

Lohmann & Rauscher International GmbH & Co. KG

Importer

🇩🇪 Germany·23 Manufacturers

MDSS GmbH

Authorized representative

🇩🇪 Germany·388 Manufacturers·16562 Devices