21 results · 67ms · Sources: EU EUDAMED, US FDA

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AVITA Medical Americas, LLC

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

Avita Medical Americas LLC

FDA registration
Avita Medical Americas LLC·3 products·🇺🇸 United States

AVITA MEDICAL AMERICAS LLC

FDA registration
AVITA MEDICAL AMERICAS LLC·2 products·🇺🇸 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·00851707004200·RECELL Autologous Cell Harvesting Device

RECELL

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

RECELL GO

FDA UDI
AVITA MEDICAL AMERICAS, LLC·00851707004279·RECELL GO Autologous Cell Harvesting Device (Pr...

RECELL GO mini

FDA UDI
AVITA MEDICAL AMERICAS, LLC·00851707004361·RECELL GO mini Autologous Cell Harvesting Devic...

RECELL GO

FDA UDI
AVITA MEDICAL AMERICAS, LLC·00851707004286·RECELL GO Autologous Cell Harvesting Device (Pr...

RECELL

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

RECELL GO

FDA Adverse Event
Injury ·AVITA MEDICAL AMERICAS LLC.·Product code QCZ·September 27, 2024

RECELL GO

FDA Adverse Event
Malfunction ·AVITA MEDICAL AMERICAS, LLC·Product code QCZ·March 12, 2026

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