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Sovereign Compact OPO65

by Johnson & Johnson Surgical Vision, Inc.

Ref OPO65

Sovereign Compact OPO65 is a device classified as Class IIa in the EU and Class I in the US made by Johnson & Johnson Surgical Vision, Inc., registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI B-USMF0000389680021356E) and listed in FDA GUDID since 2 Sep 2016 (UDI-DI D-USMF0000389680021356E), 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-USMF0000389680021356E Basic UDI-DI D-USMF0000389680021356EUDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF0000389680021356E UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-USMF0000389680021356E registered 30 Jul 2026 Active
  • FDA GUDID UDI-DI D-USMF0000389680021356E listed 2 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-USMF0000389680021356E
  2. Registered EUDAMED B-USMF0000389680021356E

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  • Withdrawn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
Sovereign Compact
Generic name
Surgical irrigation tubing set, reusable
Model / Ref / Catalog
OPO65
Primary DI / UDI-DI
D-USMF0000389680021356E EUDAMED
05050474520936 GUDID
Basic UDI-DI
B-USMF0000389680021356E
FDA product code
KYG
EMDN code
Z1212020785 Phaco-vitrectomy instruments - consumables
GMDN term
Surgical irrigation tubing set, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
886.4360
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-USMF0000389680021356E
GUDID
05050474520936
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF0000389680021356E; FDA GUDID lists 05050474520936), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical irrigation tubing set, reusable

Similar devices in this category

Other devices filed under PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES.

Other devices from Johnson & Johnson Surgical Vision, Inc.

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

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)