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Haemonetics BPFAPLUS

by Haemonetics Corporation

Ref BPFAPLUSModel High Efficiency Post-Process Filter System for Leucocyte Removal from Red Cells

Haemonetics BPFAPLUS is a device classified as Class IIb in the EU and Class II in the US made by Haemonetics Corporation, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-10887691313940), listed under FDA premarket submission BK910019 and listed in FDA GUDID since 12 Dec 2016 (UDI-DI 10887691313940), withdrawn (EUDAMED), active (FDA premarket submission) as of 7 Nov 2026.

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK910019

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10887691313940 Basic UDI-DI 10887691313940UDI-DIDate4 Nov 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number10887691313940 UDI-DI Date12 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK910019 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10887691313940 registered 4 Nov 2026 Withdrawn
  • FDA premarket submission BK910019 Active
  • FDA GUDID UDI-DI 10887691313940 listed 12 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10887691313940
  2. Registered EUDAMED B-10887691313940

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
High Efficiency Post-Process Filter System for Leucocyte Removal from Red Cells EUDAMED
Haemonetics GUDID
Generic name
Blood transfusion filter
Model / reference
BPFAPLUS, High Efficiency Post-Process Filter System for Leucocyte Removal from Red Cells
Primary DI / UDI-DI
10887691313940
Basic UDI-DI
B-10887691313940
FDA product code
CAK
EMDN code
B02010201 Laboratory erythrocytes (rbc) leukoreduction filters
GMDN term
Blood transfusion filter
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
880.5440
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 transfusion filter

Cleared under the same submission (BK910019)

and 2 more cleared under BK910019

Similar devices

Other devices filed under FDA product code CAK (Microfilter, blood transfusion).

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)