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STA® - Thrombin 2

by Diagnostica Stago

Ref 00611Model STA® - Thrombin

STA® - Thrombin 2 (00611) is a device classified as Class B in the EU and Class II in the US made by Diagnostica Stago, registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI 360745099TT000199), cleared under FDA 510(k) K884384 on 28 Dec 1988 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 13607450006114), active as of 22 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K884384

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number360745099TT000199 Basic UDI-DI 13607450006114UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number13607450006114 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK884384 Date28 Dec 1988DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 360745099TT000199 registered 20 Apr 2026 Active
  • FDA 510(k) K884384 decided 28 Dec 1988 Active
  • FDA GUDID UDI-DI 13607450006114 listed 15 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K884384
  2. Listed FDA GUDID 13607450006114
  3. Registered EUDAMED 360745099TT000199

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Thrombin time (TT) IVD, kit, clotting
Model / reference
STA® - Thrombin, 00611
Primary DI / UDI-DI
13607450006114
Basic UDI-DI
360745099TT000199
Unit of use DI
03607450006117
510(k) Number
FDA product code
GJA
EMDN code
W0103020103 Thrombin time / reptilase / batroxobin time
GMDN term
Thrombin time (TT) IVD, kit, clotting
Device class
Class B EUDAMED
Class II GUDID
Regulation number
864.7875
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FR-MF-000017089

Similar devices in this category

Other devices filed under THROMBIN TIME / REPTILASE / BATROXOBIN TIME.

Other devices from Diagnostica Stago

See all devices from Diagnostica Stago →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)