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Arisure YM058

by Yukon Medical, LLC

Ref YM058Model Arisure

Arisure YM058 is a medical device (EU MDD Class IIa; FDA Class II; FDA product code FPA, Set, Administration, Intravascular; EMDN category infusion tubing adapters and connectors) made by Yukon Medical, LLC, registered in EUDAMED on 21 Apr 2023 (Basic UDI-DI B-00851891007186) and listed in FDA GUDID since 22 Oct 2018 (UDI-DI 00851891007186), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00851891007186 Basic UDI-DI 00851891007186UDI-DIDate21 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00851891007186 UDI-DI Date22 Oct 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00851891007186 registered 21 Apr 2023 Active
  • FDA GUDID UDI-DI 00851891007186 listed 22 Oct 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00851891007186
  2. Registered EUDAMED B-00851891007186

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  • Withdrawn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
Arisure Closed Male Luer EUDAMED
Arisure GUDID
Generic name
Negative-pressure intravenous line needleless valve-connector
Model / Ref / Catalog
YM058, Arisure
Primary DI / UDI-DI
00851891007186
Basic UDI-DI
B-00851891007186
FDA product code
FPA
EMDN code
A070103 Infusion tubing adapters and connectors
GMDN term
Negative-pressure intravenous line needleless valve-connector
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5440
EU registration type
Legacy device (under a directive)
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

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: Negative-pressure intravenous line needleless valve-connector

Similar devices in this category

Other devices filed under INFUSION TUBING ADAPTERS AND CONNECTORS.

Other devices from Yukon Medical, LLC

See all devices from Yukon Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)