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BloodTrack 4.x.x

by Haemonetics Corporation

Ref BloodTrack

BloodTrack 4.x.x is a device classified as Class IIb in the EU and Class II in the US made by Haemonetics Corporation, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 081274701HSS0022R), listed under FDA premarket submission BK140133 (1 earlier submission) and listed in FDA GUDID since 15 Dec 2016 (UDI-DI 00812747010002), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK140133

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081274701HSS0022R Basic UDI-DI 00812747010002UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812747010002 UDI-DI Date15 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK140133 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081274701HSS0022R registered 8 Sep 2026 Active
  • FDA premarket submission BK140133 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00812747010002 listed 15 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00812747010002
  2. Registered EUDAMED 081274701HSS0022R

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  • Withdrawn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
BloodTrack
Generic name
Clinical laboratory information system application software
Model / reference
BloodTrack EUDAMED
4.x.x GUDID
Primary DI / UDI-DI
00812747010002
Basic UDI-DI
081274701HSS0022R
FDA product code
MMH
EMDN code
Z121799 Blood transfusion instruments - other
GMDN term
Clinical laboratory information system application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
864.9165
Special device type
Software
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BloodTrack
GUDID
4.x.x
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: Clinical laboratory information system application software

Cleared under the same submission (BK140133)

Similar devices in this category

Other devices filed under BLOOD TRANSFUSION INSTRUMENTS - OTHER.

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)