Skip to content

SkinPen Precision Elite

by Crown Aesthetics EUDAMED

Active European Union

Ref F5SP543Model F5SP544

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850035498SPETK48 Basic UDI-DIDate22 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
SkinPen Precision Elite Treatment Kit
Model / Reference
F5SP544, F5SP543
Primary DI / UDI-DI
00850060751639
Basic UDI-DI
0850035498SPETK48
Unit of Use DI
00850060751622
EMDN Code
V901699 Specialist surgical instruments and kits not included in other classes, single-use - other
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000013823
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: General internal orthopaedic fixation system implantation kit

Other devices from Crown Aesthetics

See all devices from Crown Aesthetics →

Properties

  • Sterile

Other properties (12)

  • 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