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aZure C-system Final Implant Drill, 4.3 mm (D) x 11.5 mm (L)

by INTAI Technology Corp.

Ref DI0SK10030Model Drill

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987675DR0001F6 Basic UDI-DI 04719874673406UDI-DIDate14 Nov 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Drill
Model / Reference
Drill, DI0SK10030
Primary DI / UDI-DI
04719874673406
Basic UDI-DI
471987675DR0001F6
EMDN Code
L99 Surgical instruments, reusable - other
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
TW-MF-000001158
Authorised representative
Lotus NL B.V. NL-AR-000000121

Related devices

Category: Surgical retraction system, reusable

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Properties

  • 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