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ALN 2in1 RS

by Aln France EUDAMEDGUDID

Ref RK-2010

Product code DTKEMDN C019005

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000316890 Date23 Jul 2026IssuedStatusActive expires 13 Nov 2029
United StatesGUDID listing GUDID Number03760017680127 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • 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)
  • 1000316897 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    23 Jul 2026
    Expires
    26 Oct 2030
    Reason
    Mnf data change
  • 1000316890 Amended

    Quality management system 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 2in1 RS EUDAMED
ALN 2in1 GUDID
Generic Name
Vena cava filter extraction/repositioning kit
Device Name
Vena Cava Filter Removal or Repositioning Kit
Model / Reference
RK-2010
Primary DI / UDI-DI
03760017680127
Basic UDI-DI
376001768KIT017M
510(k) Number
FDA Product Code
DTK
EMDN Code
C019005 Retrieving systems for vascular foreign bodies
GMDN Term
Vena cava filter extraction/repositioning kit
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.3375
Market of Registration
France
Commercial Distribution
In Commercial Distribution

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
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (18)
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (2)

  • EUDAMED b5384db3-55c2-48d6-9501-a929654d03a8 61 fields · synced 22 Oct 2026
  • FDA UDI 72f3ce54-54b6-4022-a837-cfa53dedd828 35 fields · synced 29 May 2026