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Recell®

by AVITA Medical Americas, LLC 2 variants

Ref C3RL01:EU

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00851707004019 Basic UDI-DI 00851707004019UDI-DIDate23 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
C3RL01:EU
Primary DI / UDI-DI
00851707004019
Basic UDI-DI
B-00851707004019
EMDN Code
Z12019003 Wound treatment equipment
Device Class
Class III
Special Device Type
-1192
EU market of registration
Northern Ireland

Manufacturer details

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

Other devices from AVITA Medical Americas, LLC

See all devices from AVITA Medical Americas, LLC →

Properties

  • Sterile
  • Animal Tissues

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No