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Zhoabex Enhance

by Rose Pharma S.A.

Ref ZHOABEX ENHANCE

Active European Union

CE MDR 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-07640187920291 Basic UDI-DI 07640187920291UDI-DIDate18 Sep 2026RegisteredStatusActive EUDAMED: not on the EU market
European UnionCE/MDD NumberB-07640187920291 Basic UDI-DI 07640187920291UDI-DIDate18 Sep 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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/MDR, CE/MDD Active

Specification

EUDAMED

Device Name
Ha Dermal Filler 2.0
Model / Reference
ZHOABEX ENHANCE
Primary DI / UDI-DI
07640187920291
Basic UDI-DI
B-07640187920291, 764018792HA20CL5M
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Medical Purpose
HA DERMAL FILLER 2.0

Manufacturer details

EUDAMED SRN
CH-MF-000033472
Authorised representative
ROSE PHARMA ITALIA S.R.L. IT-AR-000021266

Other devices from Rose Pharma S.A.

See all devices from Rose Pharma S.A. →

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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