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DENTAL STUDIO Co., Ltd.

by DENTAL STUDIO Co., Ltd. EUDAMED

Active European Union

Ref ManyModel 3500TK15

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800038206960 Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Easy Tissue Scraper
Model / Reference
3500TK15, Many
Primary DI / UDI-DI
08800038206960
Basic UDI-DI
B-08800038206960
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000050207
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Dental Studio

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: 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