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Opus

by Societe Pour La Conception Des Applications Des Techniques Electroniques 2 variants

Ref F11900, F11902

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number360982A028ad12FN Basic UDI-DI Date13 Feb 2025RegisteredStatusActive

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  • Withdrawn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
OPUS Starter Kit
Model / Reference
F11900, F11902
Primary DI / UDI-DI
03609821119006, 03609820119021
Basic UDI-DI
360982A028ad12FN, 360982SAP1DFk101000CY
Direct Marketing DI
03609821119006
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class IIa
EU market of registration
France
Medical Purpose
Dental Electronic Device

Manufacturer details

EUDAMED SRN
FR-MF-000004721

Other devices from Societe Pour La Conception Des Applications Des Techniques Electroniques

See all devices from Societe Pour La Conception Des Applications Des Techniques Electroniques →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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