Skip to content

AccuVein AV500

by Accuvein Inc.

Ref AV500

AccuVein AV500 is a device classified as Class IIa in the EU and Class I in the US made by Accuvein Inc., registered in EUDAMED on 13 Jul 2026 (Basic UDI-DI B-00850019808018) and listed in FDA GUDID since 12 Mar 2021 (UDI-DI 00850019808018), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850019808018 Basic UDI-DI 00850019808018UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850019808018 UDI-DI Date12 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850019808018 registered 13 Jul 2026 Active
  • FDA GUDID UDI-DI 00850019808018 listed 12 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850019808018
  2. Registered EUDAMED B-00850019808018

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  • Withdrawn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
AV500 EUDAMED
AccuVein GUDID
Generic name
Infrared-light vein locator
Device name
AccuVein AV500 Vein Visualization System
Model / reference
AV500
Primary DI / UDI-DI
00850019808018
Basic UDI-DI
B-00850019808018
FDA product code
KZA
EMDN code
Z120499 General medicine instruments - other
GMDN term
Infrared-light vein locator
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
880.6970
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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: Infrared-light vein locator

Similar devices in this category

Other devices filed under GENERAL MEDICINE INSTRUMENTS - OTHER.

Other devices from Accuvein Inc.

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)