Identity
- Device Name
- RECELL GO Processing Cartridge (RPC) EUDAMED
- Model / Reference
- AVRL0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851707004385 EUDAMED00851707004378 EUDAMED
- Basic UDI-DI
- 00851707004RPCAKD EUDAMED
- Direct Marketing DI
- 00851707004378 EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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 Cartridge (RPC) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00851707004RPCAKD | Class IIb | Active |
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Manufacturer
- Manufacturer
- AVITA Medical Americas, LLC
- EUDAMED SRN
- US-MF-000027367
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 5e5fd70c-1b06-4719-8cb2-5abbab893b87 61 fields · synced Oct 6, 2026
- EUDAMED b011d840-ca63-4d08-b8d7-ca19d57b068b 61 fields · synced May 19, 2026