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Platelet Aggregometer Profiler PAP-8E

by Bio/Data Corporation

Ref 106077Model PAP-8E

Platelet Aggregometer Profiler PAP-8E (106077) is a device classified as Class A in the EU and Class II in the US made by Bio/Data Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI ++G0561060774M) and listed in FDA GUDID since 30 Aug 2023 (UDI-DI *+G0561060771/ +$$+77XX/ 16D20200920F*), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++G0561060774M Basic UDI-DI *+G0561060771/ +$$+77XX/ 16D20200920F*UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number*+G0561060771/ +$$+77XX/ 16D20200920F* UDI-DI Date30 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++G0561060774M registered 27 May 2026 Active
  • FDA GUDID UDI-DI *+G0561060771/ +$$+77XX/ 16D20200920F* listed 30 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID *+G0561060771/ +$$+77XX/ 16D20200920F*
  2. Registered EUDAMED ++G0561060774M

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Platelet Aggregation Profiler, Model PAP-8E EUDAMED
Platelet Aggregometer Profiler GUDID
Generic name
Platelet aggregation analyser IVD
Device name
Platelet Aggregation Profiler
Model / Ref / Catalog
PAP-8E, 106077
Primary DI / UDI-DI
*+G0561060771/ +$$+77XX/ 16D20200920F* EUDAMED
G0561060771 GUDID
Basic UDI-DI
++G0561060774M
Direct marketing DI
*+G0561060771/ +$$+77XX/ 16D20200920F*
FDA product code
JBX
EMDN code
W0202029099 Various hemostasis instruments - other
GMDN term
Platelet aggregation analyser IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.6675
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
Primary DI / UDI-DIEUDAMED
*+G0561060771/ +$$+77XX/ 16D20200920F*
GUDID
G0561060771
Device classEUDAMED
Class A
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists *+G0561060771/ +$$+77XX/ 16D20200920F*; FDA GUDID lists G0561060771), so their flags are not compared. Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

From the manufacturer

Manufacturer's product page: Platelet Aggregometers

Related devices

Category: Platelet aggregation analyser IVD

Similar devices in this category

Other devices filed under VARIOUS HEMOSTASIS INSTRUMENTS - OTHER.

Other devices from Bio/Data Corporation

See all devices from Bio/Data Corporation →

Properties

  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)