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Neuramis Volume Lidocaine

by Medytox Inc.

Active European Union

CE MDR

Valid until

1 Apr 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880613800004DC Basic UDI-DI 08806138000040UDI-DIDate15 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR.2292-2026/0012 Active

    Technical documentation EU MDR

    Certifier
    UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292
    Issued
    2 Apr 2026
    Expires
    1 Apr 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Primary DI / UDI-DI
08806138000040
Basic UDI-DI
880613800004DC
EMDN Code
X0303 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, by a prefilled means for introduction, excluding those for tattooing – resorbable
Device Class
Class III
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
KR-MF-000028153
Authorised representative
Obelis s.a. BE-AR-000000106

Properties

  • Sterile
  • Implantable
  • Incorporates Medicinal Product

Other properties (10)

  • 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