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RECELL GO Processing Device (RPD)

EUDAMED

Class IIb (EU MDR)

Ref AVRL0204, AVRL0304, AVRL0404, AVRL0504, AVRL0604

by AVITA Medical Americas, LLC

Identity

Device Name
RECELL GO Processing Device (RPD) EUDAMED
Model / Reference
AVRL0204, AVRL0304, AVRL0404, AVRL0504, AVRL0604 EUDAMED

Identifiers

Primary DI / UDI-DI
00851707004316 EUDAMED
Basic UDI-DI
00851707004RPDNF EUDAMED
Direct Marketing DI
00851707004316 EUDAMED
EMDN Code
Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED

Classification

Device Class
Class IIb EUDAMED
Special Device Type
Software EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

RECELL GO Processing Device (RPD) by AVITA Medical Americas, LLC — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000027367
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED faf0e568-8abd-4253-8a56-6dab22b31503 61 fields · synced Jul 11, 2026
  • EUDAMED faf0e568-8abd-4253-8a56-6dab22b31503-1 61 fields · synced Jun 10, 2026