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PlasmaCon L2 32-201

by r2 Diagnostics Inc.

Ref 32-201

PlasmaCon L2 32-201 is a device classified as IVD General (EU), Class II (US) made by r2 Diagnostics Inc., registered in EUDAMED on 20 May 2026 (Basic UDI-DI B-10859394006085), cleared under FDA 510(k) K062306 on 16 Mar 2007 and listed in FDA GUDID since 15 Nov 2016 (UDI-DI 10859394006085), active as of 23 Oct 2026.

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

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K062306

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10859394006085 Basic UDI-DI 10859394006085UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10859394006085 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062306 Date16 Mar 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10859394006085 registered 20 May 2026 Active
  • FDA 510(k) K062306 decided 16 Mar 2007 Active
  • FDA GUDID UDI-DI 10859394006085 listed 15 Nov 2016 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K062306
  2. Listed FDA GUDID 10859394006085
  3. Registered EUDAMED B-10859394006085

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PlasmaCon L2
Generic name
Multiple coagulation marker IVD, control
Model / Ref / Catalog
32-201
Primary DI / UDI-DI
10859394006085
Basic UDI-DI
B-10859394006085
510(k) Number
FDA product code
GGC, GIZ
EMDN code
W0103020702 Control plasma for haemostasis
GMDN term
Multiple coagulation marker IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.5425
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General 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: Multiple coagulation factor IVD, control

Cleared under the same submission (K062306)

Similar devices in this category

Other devices filed under CONTROL PLASMA FOR HAEMOSTASIS.

Other devices from r2 Diagnostics Inc.

See all devices from r2 Diagnostics Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)