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Fiber Laser Treatment Systems

by Shanghai Apolo Medical Technology Co., Ltd. China EUDAMED

Ref 2316Model HS-231

EMDN Z12011007

Overview

Dermatological dye laser systems are designed to provide effective treatment for various skin conditions using a fiber laser technology. These devices are equipped with advanced features and specifications, including Class IIb certification, self-testing capabilities, and compatibility with specific implantable materials.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970745912316 Basic UDI-DIDate29 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
HS-231, 2316
Primary DI / UDI-DI
06970745912316
Basic UDI-DI
B-06970745912316
EMDN Code
Z12011007 Dye surgical laser
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000002904
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED a8236406-d1a8-4e52-841e-6fe9a3dfd1e7 61 fields · synced 24 Oct 2026