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Estyme Smooth

by Symatese SAS 3 variants

Ref SMOO1-302

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 linked in EUDAMED

A group certificate may exist

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 Number376017216PPFASYSMS Basic UDI-DI 03760172162223UDI-DIDate9 Jul 2026RegisteredStatusActive

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  • Withdrawn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 Active

EU market availability

Not listed: EUDAMED names no country where this device is made available.

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

Last checked 24 Oct 2026.

Specification

EUDAMED

Model / Reference
SMOO1-302
Primary DI / UDI-DI
03760172162223
Basic UDI-DI
376017216PPFASYSMS
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
Medical Purpose
ESTYME SMOOTH is indicated to correct nasolabial folds and perioral lines. ESTYME SMOOTH is injected into the dermis to hypodermis.

Manufacturer details

EUDAMED SRN
FR-PR-000033604

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Properties

  • Sterile