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Comport

by RET, Inc. 4 variants

Ref C20R6013Model COMPORT, COMPORT C, COMPORT L, COMPORT T, COMPORT TN, COMPORT PLUS, COMPORT C PLUS, COMPORT L PLUS, COMPORT T PLUS, COMPORT TN PLUS, COMPORT D PLUS

Active European Union

CE MDR

Valid until

24 May 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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 Number880949541TCF-MDRY2 Basic UDI-DI 08809495410071UDI-DIDate3 Apr 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR24/00000041 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    24 May 2024
    Expires
    24 May 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile single use IOL Placement System
Model / Reference
COMPORT, COMPORT C, COMPORT L, COMPORT T, COMPORT TN, COMPORT PLUS, COMPORT C PLUS, COMPORT L PLUS, COMPORT T PLUS, COMPORT TN PLUS, COMPORT D PLUS, C20R6013
Primary DI / UDI-DI
08809495410071
Basic UDI-DI
880949541TCF-MDRY2
EMDN Code
Q021199 Ophthalmic surgery instruments, single-use - other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000014159
Authorised representative
S.B. Pharma GmbH DE-AR-000005392

Other devices from RET, Inc.

  • Comport D Plus

    Class IIa

  • Comport C

    Class IIa

  • Comport Plus

    Class IIa

  • Comport T Plus

    Class IIa

  • Comport

    Class IIa

  • Comport L

    Class IIa

See all devices from RET, Inc. →

Properties

  • Sterile

Other properties (12)

  • 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