21 results
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67ms
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Sources: EU EUDAMED, US FDA
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
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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