Skip to content

i.Series® iBX020-GX

by HELMER Inc.

Ref iBX020-GXModel i.Series

i.Series® iBX020-GX (5110020) is a device classified as Class IIa in the EU and Class II in the US made by HELMER Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00816394021695) and listed in FDA GUDID since 6 Oct 2023 (UDI-DI 00816394021695), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816394021695 Basic UDI-DI 00816394021695UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816394021695 UDI-DI Date6 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816394021695 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00816394021695 listed 6 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816394021695
  2. Registered EUDAMED B-00816394021695

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  • Withdrawn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
i.Series EUDAMED
i.Series® GUDID
Generic name
Blood refrigerator
Model / Ref / Catalog
iBX020-GX, i.Series, 5110020
Primary DI / UDI-DI
00816394021695
Basic UDI-DI
B-00816394021695
FDA product code
KSE
EMDN code
Z121701 Blood banks refrigerators
GMDN term
Blood refrigerator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.9700
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
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: Blood refrigeratorBlood refrigerator/freezer

Similar devices in this category

Other devices filed under BLOOD BANKS REFRIGERATORS.

Other devices from HELMER Inc.

See all devices from HELMER Inc. →

Properties

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