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ClotTriever Sheath

by Inari Medical, Inc.

Ref 51-101

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

CE MDR

Valid until

8 Nov 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000332280 Date25 Sep 2026IssuedStatusActive expires 8 Nov 2028
United StatesGUDID listing GUDID Number00850291007611 UDI-DI Date22 Mar 2021ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000332280 Restricted

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    25 Sep 2026
    Expires
    8 Nov 2028
    Reason
    Other

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  • Withdrawn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

Generic Name
Thrombectomy wire-net introduction set
Device Name
ClotTriever Sheath 16Fr
ClotTriever Sheath, 16 Fr
Model / Reference
51-101
Primary DI / UDI-DI
00850291007611, 00850291007123
Basic UDI-DI
0850291007CT9Y, 085029100751-101ZC
Direct Marketing DI
00850291007611
FDA Product Code
QEW
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Thrombectomy wire-net introduction set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.5150
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 16 French
Catheter Working Length — 15 Centimeter

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

Related devices

Category: Vascular catheter introduction set, nonimplantable

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