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Smartload GAB00

by Johnson & Johnson Surgical Vision, Inc. 49 variants

Ref GAB0000225

Smartload GAB00 (GAB0000225) is a device classified as Class IIb in the EU and Class III in the US made by Johnson & Johnson Surgical Vision, Inc., registered in EUDAMED on 6 Mar 2026 (Basic UDI-DI 5050474a000459N) with CE/MDR certificate 2252965CE02 valid until 1 Mar 2027 and listed in FDA GUDID since 1 Sep 2020 (UDI-DI 05050474621831), active as of 24 Oct 2026.

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5050474a000459N Basic UDI-DI 05050474621831UDI-DIDate6 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05050474621831 UDI-DI Date1 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5050474a000459N registered 6 Mar 2026 Active· +2 more in the status table
  • FDA GUDID UDI-DI 05050474621831 listed 1 Sep 2020 Listed

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 109 days

    Quality management system EU MDR

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

Timeline

6 dated events

  1. Listed FDA GUDID 05050474621831
  2. Certificate issued EUDAMED 2252965CE02
  3. Certificate issued EUDAMED 2252965TD02
  4. Registered EUDAMED 5050474a000459N
  5. Certificate expires EUDAMED 2252965CE02
  6. Certificate expires EUDAMED 2252965TD02

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  • Withdrawn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
GAB0000225, GAB00
Primary DI / UDI-DI
05050474621831
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
GAB0000225
GUDID
GAB00
Device classEUDAMED
Class IIb
GUDID
Class III
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

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

Similar devices in this category

Other devices filed under IOLs, APHAKIC, MONOFOCAL, SPHERICAL.

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, all answered No)