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Smartload GAB00

by Johnson & Johnson Surgical Vision, Inc. 49 variants

Ref GAB0000300

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

1 Mar 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5050474a000459N Basic UDI-DI 05050474621985UDI-DIDate6 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05050474621985 UDI-DI Date1 Sep 2020ListedStatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2252965TD02 Restricted

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    16 Jul 2025
    Expires
    1 Oct 2028
    Reason
    Other
  • 2252965CE02 Expiring Supplemented Expires in 110 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    16 Jul 2025
    Expires
    1 Mar 2027
    Reason
    Other

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Sensar Monofocal 1-Piece IOL with Smartload Delivery Technology EUDAMED
Smartload GUDID
Generic name
Intraocular lens-insertion cartridge
Device name
Sensar Monofocal 1-Piece Smartload Preloaded IOL
Model / Ref / Catalog
GAB0000300, GAB00
Primary DI / UDI-DI
05050474621985
Basic UDI-DI
5050474a000459N
FDA product code
HQL
EMDN code
P030102090101 IOLs, APHAKIC, MONOFOCAL, SPHERICAL, HYDROPHOBIC ACRYLIC
GMDN term
Intraocular lens-insertion cartridge
Device class
Class IIb EUDAMED
Class III GUDID
Regulation number
886.3600
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 13.00 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
GAB0000300
GUDID
GAB00
Device classEUDAMED
Class IIb
GUDID
Class III
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Posterior-chamber intraocular lens, pseudophakicIntraocular lens-insertion cartridge

Other devices from Johnson & Johnson Surgical Vision, Inc.

See all devices from Johnson & Johnson Surgical Vision, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (19)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Sutures: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Lot / batch number: No