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STA Compact Max® 2

by Diagnostica Stago 2 variants

Ref 58989Model STA Compact Max

STA Compact Max® 2 (58989) is a device classified as Class A in the EU and Class II in the US made by Diagnostica Stago, registered in EUDAMED on 18 Nov 2022 (Basic UDI-DI 3607450INST0003UH) and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 03607450589894), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number3607450INST0003UH Basic UDI-DI 03607450589894UDI-DIDate18 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number03607450589894 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 3607450INST0003UH registered 18 Nov 2022 Active
  • FDA GUDID UDI-DI 03607450589894 listed 15 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03607450589894
  2. Registered EUDAMED 3607450INST0003UH

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  • Withdrawn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
STA Compact Max® 2 EUDAMED
STA Compact Max® (with cap piercing option) GUDID
Generic name
Coagulation analyser IVD, laboratory
Model / reference
STA Compact Max, 58989
Primary DI / UDI-DI
03607450589894
Basic UDI-DI
3607450INST0003UH
Direct marketing DI
03607450589894
FDA product code
JPA
EMDN code
W0202029099 Various hemostasis instruments - other
GMDN term
Coagulation analyser IVD, laboratory
Device class
Class A EUDAMED
Class II GUDID
Regulation number
864.5425
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 A
GUDID
Class II

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.

Manufacturer details

EUDAMED SRN
FR-MF-000017089

Similar devices in this category

Other devices filed under VARIOUS HEMOSTASIS INSTRUMENTS - OTHER.

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Properties

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