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Amts

by Woorhi Mechatronics Co., Ltd. 39 variants

Ref esteticPen by LABODERM

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001181AMTSMC Basic UDI-DI 08800118100386UDI-DIDate21 Jan 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  • Withdrawn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

Specification

EUDAMED

Device Name
Amts
Model / Reference
esteticPen by LABODERM
Primary DI / UDI-DI
08800118100386
Basic UDI-DI
88001181AMTSMC
EMDN Code
A019006 Mesotherapy needles
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000035848
Authorised representative
SMB EUROPE SAS FR-AR-000011981

Other devices from Woorhi Mechatronics Co., Ltd.

See all devices from Woorhi Mechatronics Co., Ltd. →

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