Skip to content

Perla

by Francehopital SAS 2 variants

Ref HK6DMXXXXModel PerlaPlus

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805577667PerlaPlus2U Basic UDI-DIDate30 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
PerlaPlus
Model / Reference
PerlaPlus, HK6DMXXXX
Primary DI / UDI-DI
08055776670157
Basic UDI-DI
805577667PerlaPlus2U
Direct Marketing DI
08055776670157
EMDN Code
V0899 Medical support equipment - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
FR-MF-000038034

Other devices from Francehopital SAS

See all devices from Francehopital SAS →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No