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Lyophilized Platelets 10mL

by Bio/Data Corporation

Ref 101258

Lyophilized Platelets 10mL (101258) 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 ++G0561012583Q) and listed in FDA GUDID since 23 Mar 2022 (UDI-DI *+G0561012580/ $$0100060XXXX+*), active as of 24 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++G0561012583Q Basic UDI-DI *+G0561012580/ $$0100060XXXX+*UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number*+G0561012580/ $$0100060XXXX+* UDI-DI Date23 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++G0561012583Q registered 27 May 2026 Active
  • FDA GUDID UDI-DI *+G0561012580/ $$0100060XXXX+* listed 23 Mar 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID *+G0561012580/ $$0100060XXXX+*
  2. Registered EUDAMED ++G0561012583Q

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  • Withdrawn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
Lyophilized Platelets
Generic name
von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
Model / Ref / Catalog
101258, 10mL
Primary DI / UDI-DI
*+G0561012580/ $$0100060XXXX+* EUDAMED
G0561012580 GUDID
Basic UDI-DI
++G0561012583Q
FDA product code
GGP
EMDN code
W0103010605, W01030199
GMDN term
von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.7290
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
101258
GUDID
10mL
Primary DI / UDI-DIEUDAMED
*+G0561012580/ $$0100060XXXX+*
GUDID
G0561012580
Device classEUDAMED
Class A
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists *+G0561012580/ $$0100060XXXX+*; FDA GUDID lists G0561012580), 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.

Related devices

Category: von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

Similar devices in this category

Other devices filed under HAEMATOLOGY TESTS - RT & POC.

Other devices from Bio/Data Corporation

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Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)