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ALN Optional Vena Cava Filter

by Aln France EUDAMEDGUDID

Ref FJ.120096 Product code DTKEMDN C01050101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000316890 Date23 Jul 2026IssuedStatusActive expires 13 Nov 2029
United StatesGUDID listing GUDID Number03760017680011 UDI-DIDate26 Oct 2018ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000316890 Amended

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    23 Jul 2026
    Expires
    13 Nov 2029
    Reason
    Mnf data change
  • 1000316916 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    23 Jul 2026
    Expires
    13 Nov 2029
    Reason
    Mnf data change

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
ALN Optional Vena Cava Filter EUDAMED
ALN Optional Vena Cava Filter - Jugular Approach GUDID
Generic Name
Vena cava filter, temporary/permanent
Model / Reference
FJ.120096
Primary DI / UDI-DI
03760017680011
Basic UDI-DI
376001768VCF017W
FDA Product Code
DTK
EMDN Code
C01050101 Vena cava filters, retrievable
GMDN Term
Vena cava filter, temporary/permanent
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.3375
Market of Registration
France
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000000841

Other devices from Aln

See all devices from Aln →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (16)
  • 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

Sources (2)

  • EUDAMED ccd8d3da-b5f0-46e2-a95e-265cb92a9dc4 61 fields · synced 22 Oct 2026
  • FDA UDI 7639b3f7-b21e-473f-8774-c6f3cf2fb0a0 34 fields · synced 30 May 2026