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EVA NEXUSTM Custom Cartridge with 0.5 L collection bag 9500.CAR01

by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Ref 9500.CAR01

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08717872034164 Basic UDI-DI 08717872034164UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717872034164 UDI-DI Date11 Jul 2023ListedStatusListed GUDID: in commercial distribution

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.

Recalls

6 recalls · 6 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2322-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2324-2026 FDA Class II initiated 30 Apr 2026
    • Ongoing Z-2323-2026 FDA Class II initiated 30 Apr 2026

    An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

  • 3 recalls, same reason

    • Ongoing Z-1333-2024 FDA Class II initiated 15 Jan 2024
    • Ongoing Z-1332-2024 FDA Class II initiated 15 Jan 2024
    • Ongoing Z-1331-2024 FDA Class II initiated 15 Jan 2024

    When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
EVA NEXUS Custom Cartridge with 0.5 L collection bag EUDAMED
EVA NEXUSTM Custom Cartridge with 0.5 L collection bag GUDID
Generic Name
Ophthalmic surgical procedure kit, non-medicated, single-use
Model / Reference
9500.CAR01
Primary DI / UDI-DI
08717872034164
Basic UDI-DI
B-08717872034164
510(k) Number
FDA Product Code
HQC, HQE
EMDN Code
Q021113 Ophthalmic surgery instrument kits, single-use
GMDN Term
Ophthalmic surgical procedure kit, non-medicated, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.4670, 886.4150
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Ophthalmic surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K213467)

Show all (12)

Other devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

See all devices from D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No