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LB-14 & LB-15 Prism Bar Set

by Gulden Ophthalmics

Ref 11315

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, self-declared

Class I: no certifier involved

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 Number++B091PrismBarsE2 Basic UDI-DI +B091113150UUDI-DIDate18 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Prism Bar
Model / Reference
11315
Primary DI / UDI-DI
+B091113150U
Basic UDI-DI
++B091PrismBarsE2
EMDN Code
Z12120299 Therapeutic and surgical ophtholmological treatments instruments - other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000008608
Authorised representative
QbD RepS BV BE-AR-000000040

From the manufacturer

Manufacturer's product page: Prism Bars & Sets

Other devices from Gulden Ophthalmics

See all devices from Gulden Ophthalmics →

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