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Acp 215 02215-220-E

by Haemonetics Corporation

Ref 02215-220-EModel ACP 215

Acp 215 02215-220-E is a device classified as Class IIa in the EU and Class II in the US made by Haemonetics Corporation, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-30812747015817), listed under FDA premarket submission BK030062 (2 earlier submissions) and listed in FDA GUDID since 31 Jan 2017 (UDI-DI 30812747015817), active as of 25 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK030062

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-30812747015817 Basic UDI-DI 30812747015817UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30812747015817 UDI-DI Date31 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK030062 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30812747015817 registered 7 Oct 2026 Active
  • FDA premarket submission BK030062 Active· +2 more in the status table
  • FDA GUDID UDI-DI 30812747015817 listed 31 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 30812747015817
  2. Registered EUDAMED B-30812747015817

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Acp 215
Generic name
Blood cell freeze/thaw system
Model / reference
02215-220-E, ACP 215
Primary DI / UDI-DI
30812747015817
Basic UDI-DI
B-30812747015817
FDA product code
KSW
EMDN code
Z12170401 Blood donation apheresis equipment
GMDN term
Blood cell freeze/thaw system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
864.9145
EU registration type
Legacy device (under a directive)
EU market of registration
Hungary
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 cell freeze/thaw system

Cleared under the same submission (BK030062)

Cleared under the same submission (BK040077)

Similar devices in this category

Other devices filed under BLOOD TRANSFUSION INSTRUMENTS.

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (21, all answered No)