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OphteisBio 1.8%

by Rayner Intraocular Lenses Limited

Ref S-OPB18

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 Number5029867OPB18XJ Basic UDI-DI 05029867044120UDI-DIDate28 Aug 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  • Withdrawn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
OphteisBio 1.8%
Model / Reference
S-OPB18
Primary DI / UDI-DI
05029867044120
Basic UDI-DI
5029867OPB18XJ
Direct Marketing DI
05029867044120
EMDN Code
Q02030301 Ophthalmology, hyaluronic acid and derivatives
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000018056
Authorised representative
Rayner Surgical GmbH DE-AR-000015767

Other devices from Rayner Intraocular Lenses, Ltd.

See all devices from Rayner Intraocular Lenses, Ltd. →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No