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Laminar OPOS20L

by Johnson & Johnson Surgical Vision, Inc.

Ref OPOS20L

Laminar OPOS20L is a device classified as Class IIa in the EU and Class II in the US made by Johnson & Johnson Surgical Vision, Inc., registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI B-USMF0000389680021025X) and listed in FDA GUDID since 2 Sep 2016 (UDI-DI D-USMF0000389680021025X), active as of 22 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF0000389680021025X Basic UDI-DI D-USMF0000389680021025XUDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF0000389680021025X UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-USMF0000389680021025X registered 30 Jul 2026 Active
  • FDA GUDID UDI-DI D-USMF0000389680021025X listed 2 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-USMF0000389680021025X
  2. Registered EUDAMED B-USMF0000389680021025X

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  • Withdrawn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
Laminar
Generic name
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Model / Ref / Catalog
OPOS20L
Primary DI / UDI-DI
D-USMF0000389680021025X EUDAMED
05050474500389 GUDID
Basic UDI-DI
B-USMF0000389680021025X
FDA product code
HQC
EMDN code
Q020699 Phacoemulsification devices - other
GMDN term
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.4670
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF0000389680021025X
GUDID
05050474500389
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF0000389680021025X; FDA GUDID lists 05050474500389), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

Similar devices in this category

Other devices filed under PHACOEMULSIFICATION DEVICES - OTHER.

Other devices from Johnson & Johnson Surgical Vision, Inc.

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

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Reusable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)