Identity
- Device Name
- RECELL GO Procedure Pack A EUDAMED
- Model / Reference
- AVRL0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851707004408 EUDAMED
- Basic UDI-DI
- 00851707004RGPPL5 EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa 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 Procedure Pack A by AVITA Medical Americas, LLC — Class IIa — 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 | 00851707004RGPPL5 | Class IIa | 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 (1)
- EUDAMED 4c95dd23-24f5-4ad9-8d00-3ac24d382c9b 61 fields · synced Jun 18, 2026