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Driver Handpiece He H5.0XØ4MM

by S.I.N. Implant System Ltda.

Ref CTWHE 504EModel DRIVER WITHOUT DLC

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number999520000011JK Basic UDI-DI 07899995277145UDI-DIDate30 May 2026RegisteredStatusActive

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  • Withdrawn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
Driver
Model / Reference
DRIVER WITHOUT DLC, CTWHE 504E
Primary DI / UDI-DI
07899995277145
Basic UDI-DI
999520000011JK
EMDN Code
L159099 Odontostomatology instruments, reusable - other
Device Class
Class IIa
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
BR-MF-000019848
Authorised representative
Biohorizons Camlog Portugal, Unipessoal, Lda. PT-AR-000052515

Other devices from S.I.N. Implant System Ltda

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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