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MILANO -Basic Version

by Delcon Srl

Part of a family of 19 devices: see the family page

Ref HMIX4.02

MILANO -Basic Version (HMIX4.02) is a device classified as Class I in the EU and Class II in the US made by Delcon SRL, registered in EUDAMED on 27 Dec 2021 (Basic UDI-DI 803392853MIXEGQ), listed under FDA premarket submission BK190429 and listed in FDA GUDID since 12 Mar 2020 (UDI-DI 08033928530184), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK190429

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803392853MIXEGQ Basic UDI-DI 08033928530184UDI-DIDate27 Dec 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number08033928530184 UDI-DI Date12 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK190429 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803392853MIXEGQ registered 27 Dec 2021 Active
  • FDA premarket submission BK190429 Active
  • FDA GUDID UDI-DI 08033928530184 listed 12 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08033928530184
  2. Registered EUDAMED 803392853MIXEGQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
MILANO -Basic Version EUDAMED
HemoMix 4 GUDID
Generic name
Blood donation rocker
Device name
Mixer
Model / reference
HMIX4.02 EUDAMED
HMIX4.02 standard version GUDID
Primary DI / UDI-DI
08033928530184
Basic UDI-DI
803392853MIXEGQ
FDA product code
MYJ
EMDN code
B0180 Blood bags and kits - accessories
GMDN term
Blood donation rocker
Device class
Class I EUDAMED
Class II GUDID
Regulation number
864.9195
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HMIX4.02
GUDID
HMIX4.02 standard version
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IT-MF-000014234

Similar devices in this category

Other devices filed under BLOOD BAGS AND KITS - ACCESSORIES.

Other devices from Delcon SRL

See all devices from Delcon SRL →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)