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BlueShaper PRO

by Shenzhen Denco Medical Co., Ltd. China EUDAMED

Ref ZBS31ZPRO5Model BlueShaper PRO sterile 31mm Z5

EMDN Q030311

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06975718052259 Basic UDI-DIDate13 Aug 2024RegisteredStatusActive

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 25 Oct 2026

Device Name
Dental Root Canal Instruments
Model / Reference
BlueShaper PRO sterile 31mm Z5, ZBS31ZPRO5
Primary DI / UDI-DI
06975718052259
Basic UDI-DI
B-06975718052259
EMDN Code
Q030311 ENT surgery rasps and files, single-use
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014271
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Shenzhen Denco Medical Co., Ltd.

See all devices from Shenzhen Denco Medical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • 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

Sources (1)

  • EUDAMED 48d79ec8-81d1-46ba-8a73-b27537f327b5 61 fields · synced 25 Oct 2026