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Clot catcher 906-020

by Radiometer Medical ApS

Ref 906-020

Clot catcher 906-020 is a device classified as Class A in the EU and Class II in the US made by Radiometer Medical ApS, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 57006900089NK) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05700699060204), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number57006900089NK Basic UDI-DI 05700699060204UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05700699060204 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 57006900089NK registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 05700699060204 listed 1 Sep 2016 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 05700699060204
  2. Registered EUDAMED 57006900089NK

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  • Withdrawn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
ABL700 Series and ABL800 FLEX Clot Catcher EUDAMED
Clot catcher GUDID
Generic name
Analyser blood clot protection filter IVD
Model / Ref / Catalog
906-020
Primary DI / UDI-DI
05700699060204
Basic UDI-DI
57006900089NK
Unit of use DI
55700699060209
FDA product code
CHL, CGA, CEM, GKF, JFP, JJS, JGS, CGZ, KHP, CIG, MQM
EMDN code
W02079099 Various general purpose IVD instruments - other
GMDN term
Analyser blood clot protection filter IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1120, 862.1345, 862.1600, 864.5600, 862.1145, 862.1660, 862.1665, 862.1170, 862.1450, 862.1110, 862.1113
EU registration type
Standard device
EU market of registration
Denmark
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.

Related devices

Category: Analyser blood clot protection filter IVD

Similar devices in this category

Other devices filed under VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER.

Other devices from Radiometer Medical ApS

See all devices from Radiometer Medical ApS →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)