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ThermoGenesis AXP 80056

by Thermogenesis Corp.

Ref 80056Model AXP II Device

ThermoGenesis AXP 80056 is a device classified as Class IIa in the EU and Class II in the US made by Thermogenesis Corp., registered in EUDAMED on 26 Oct 2022 (Basic UDI-DI 088636AXPIICMES), listed under FDA premarket submission BK180198 and listed in FDA GUDID since 14 Sep 2023 (UDI-DI 10886368000619), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK180198

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10886368000619 UDI-DI Date14 Sep 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number088636AXPIICMES Basic UDI-DI 10886368000619UDI-DIDate26 Oct 2022RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberBK180198 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 088636AXPIICMES registered 26 Oct 2022 Active
  • FDA premarket submission BK180198 Active
  • FDA GUDID UDI-DI 10886368000619 listed 14 Sep 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 088636AXPIICMES
  2. Listed FDA GUDID 10886368000619

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  • Withdrawn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
Axp EUDAMED
ThermoGenesis AXP GUDID
Generic name
Blood centrifugation system containment kit
Model / Ref / Catalog
80056, AXP II Device
Primary DI / UDI-DI
10886368000619
Basic UDI-DI
088636AXPIICMES
Direct marketing DI
00886368000612
FDA product code
OAO
EMDN code
B030203 Single plasma components removal devices and kits
GMDN term
Blood centrifugation system containment kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.9900
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
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

Cleared under the same submission (BK180198)

Similar devices in this category

Other devices filed under APHERESIS THERAPY DEVICES.

Other devices from Thermogenesis Corp.

See all devices from Thermogenesis Corp. →

Properties

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