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Versicon® JPPL0350

by Joimax, Inc.

Ref JPPL0350

Versicon® JPPL0350 is a device classified as Class IIa in the EU and Class II in the US made by Joimax, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI B-04250337104018) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04250337104018), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04250337104018 Basic UDI-DI 04250337104018UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250337104018 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04250337104018 registered 21 May 2026 Active
  • FDA GUDID UDI-DI 04250337104018 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04250337104018
  2. Registered EUDAMED B-04250337104018

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  • Withdrawn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
Disposable Patient Line EUDAMED
Versicon® GUDID
Generic name
Surgical irrigation tubing set, single-use
Model / reference
JPPL0350
Primary DI / UDI-DI
04250337104018
Basic UDI-DI
B-04250337104018
FDA product code
FQH
EMDN code
A03040299 Irrigation kits, single-use - other
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5475
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Surgical irrigation tubing set, single-use

Similar devices in this category

Other devices filed under IRRIGATION KITS, SINGLE-USE - OTHER.

Other devices from Joimax, Inc.

See all devices from Joimax, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)