Identity
- Trade Name
- RECELL® EUDAMED
- Model / Reference
- C3RL01-B:EU EUDAMEDC3RL01:EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851707004118 EUDAMED00851707004019 EUDAMED
- Basic UDI-DI
- B-00851707004118 EUDAMEDB-00851707004019 EUDAMED
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Recell® by AVITA Medical Americas, LLC — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00851707004118 | Class III | 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 c1df05ce-5dd6-44ee-91c0-8587b9c37601 61 fields · synced Jul 21, 2026
- EUDAMED 6db2e549-5996-483e-bfed-99673347c94b 61 fields · synced May 18, 2026