Skip to content

Amts

by Woorhi Mechatronics Co., Ltd. South Korea EUDAMED

Ref PENShape

EMDN A019006

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001181AMTSMC Basic UDI-DIDate21 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Amts
Model / Reference
PENShape
Primary DI / UDI-DI
08800118100393
Basic UDI-DI
88001181AMTSMC
EMDN Code
A019006 Mesotherapy needles
Device Class
Class IIa
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 & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 6ca03469-507c-4e39-a5d2-3ea6378ffcdf 61 fields · synced 22 Oct 2026