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Opus

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

Ref F11901

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 Number360982SAP1DFk101000CY Basic UDI-DI 03609820119014UDI-DIDate3 Jul 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  • Withdrawn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
F11901
Primary DI / UDI-DI
03609820119014
Basic UDI-DI
360982SAP1DFk101000CY
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class IIa
Medical Purpose
Dental Electronic Device

Manufacturer details

EUDAMED SRN
FR-PR-000021961

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Properties

Other properties (1)

  • Sterile: No