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Medical Handpiece with Accessories

by ScienceMedic Co., Ltd. South Korea EUDAMED

Ref SMB-100T EMDN Z12130501

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800034448975 Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
SMB-100T
Primary DI / UDI-DI
08800034448975
Basic UDI-DI
B-08800034448975
EMDN Code
Z12130501 Motorised orthopaedic surgery systems
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
KR-MF-000035261
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from ScienceMedic Co., Ltd.

See all devices from ScienceMedic Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 444c2dbe-8d72-40ac-aa9c-e8b02246e8e8 61 fields · synced 25 Oct 2026