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AccuVein HF550

by Accuvein Inc.

Ref HF550

AccuVein HF550 is a Class I device made by Accuvein Inc., registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-00850019808032) and listed in FDA GUDID since 12 Mar 2021 (UDI-DI 00850019808032), 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-00850019808032 Basic UDI-DI 00850019808032UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850019808032 UDI-DI Date12 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850019808032 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00850019808032 listed 12 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850019808032
  2. Registered EUDAMED B-00850019808032

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  • Withdrawn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
AccuVein
Generic name
Transportable medical equipment stand, non-powered
Device name
HF550 Wheeled Hands-Free Stand
Model / reference
HF550
Primary DI / UDI-DI
00850019808032
Basic UDI-DI
B-00850019808032
FDA product code
KZA
EMDN code
Z110601 Laser imaging scanner
GMDN term
Transportable medical equipment stand, non-powered
Device class
Class I
Regulation number
880.6970
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Transportable medical equipment stand, non-powered

Similar devices in this category

Other devices filed under LASER IMAGING SCANNER.

Other devices from Accuvein Inc.

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)