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ZMB00I0160

by Johnson & Johnson Surgical Vision, Inc.

Ref ZMB00I0160Model ZMB00

Active European Union

CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-USMF0000389680014906W Basic UDI-DI D-USMF0000389680014906WUDI-DIDate27 Feb 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
ZMB00, ZMB00I0160
Primary DI / UDI-DI
D-USMF0000389680014906W
Basic UDI-DI
B-USMF0000389680014906W
EMDN Code
P030102100201 IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000038968
Authorised representative
AMO Ireland IE-AR-000013513

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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