AVITA Medical Americas, LLC

Manufacturer

🇺🇸 United States·2 Basic UDI-DIs·2 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

RECELL

FDA registration

Avita Medical Americas LLC·1 product·🇺🇸 United States

RECELL

FDA registration

Avita Medical Americas LLC·1 product·🇺🇸 United States

RECELL

FDA registration

AVITA MEDICAL AMERICAS LLC·1 product·🇺🇸 United States

RECELL

FDA registration

AVITA MEDICAL AMERICAS LLC·1 product·🇺🇸 United States

PermeaDerm B, C and G

FDA registration

Avita Medical Americas LLC·1 product·🇺🇸 United States

RECELL®

Device

EU MDD · Eu Md Class 3 ·AVITA Medical Americas, LLC·On the market·21 countries

RECELL®

Device

EU MDD · Eu Md Class 3 ·AVITA Medical Americas, LLC·On the market·21 countries

RECELL

FDA UDI

AVITA MEDICAL AMERICAS, LLC·00851707004149·RECELL Autologous Cell Harvesting Device

RECELL

FDA UDI

AVITA MEDICAL AMERICAS, LLC·00851707004200·RECELL Autologous Cell Harvesting Device

RECELL

FDA UDI

AVITA MEDICAL AMERICAS, LLC·00851707004262·RECELL Autologous Cell Harvesting Device

C3RL01:EU

Basic UDI-DI

EU MDD · Eu Md Class 3 ·AVITA Medical Americas, LLC·1 device

C3RL01-B:EU

Basic UDI-DI

EU MDD · Eu Md Class 3 ·AVITA Medical Americas, LLC·1 device

US19/819943480

Certificate

MDD Annex II (excluding section 4)·AVITA Medical Americas, LLC·SGS Belgium NV·2 Basic UDI-DIs

US19/819943500

Certificate

MDD Annex II Section 4·AVITA Medical Americas, LLC·SGS Belgium NV·2 Basic UDI-DIs

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

MedEnvoy Global BV

Importer

🇳🇱 Netherlands·234 Manufacturers

MDSS GmbH

Authorized representative

🇩🇪 Germany·388 Manufacturers·16562 Devices

Advena Limited

Authorized representative

🇲🇹 Malta·467 Manufacturers·13717 Devices