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Artix AX, 115 cm

by Inari Medical, Inc.

Ref 31-102Model 31-101

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081012371ARTIXCT76 Basic UDI-DI 00810123710256UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810123710256 UDI-DI Date24 Apr 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Artix AX, 115 cm EUDAMED
Artix™ AX GUDID
Artix AX GUDID
Generic Name
Thrombectomy suction catheter
Device Name
Artix AX, 85 cm
Model / Ref / Catalog
31-101, 31-102
Primary DI / UDI-DI
00810123710256, 00850291007468
Basic UDI-DI
081012371ARTIXCT76
Direct Marketing DI
00810123710256
510(k) Number
FDA Product Code
QEW, KRA
EMDN Code
C019002 Embolectomy catheters
GMDN Term
Thrombectomy suction catheter
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.5150, 870.1210
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008693
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Inari Medical, Inc.

See all devices from Inari Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No