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ALN Optional Vena Cava Filter - Jugular Approach with Hook FJ.HOOK

by A.L.N.

Ref FJ.HOOK

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

CE MDR

Valid until

13 Nov 2029

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000316890 Date23 Jul 2026IssuedStatusActive expires 13 Nov 2029
United StatesGUDID listing GUDID Number03760017680059 UDI-DI Date26 Oct 2018ListedStatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000316890 Active Amended

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    23 Jul 2026
    Expires
    13 Nov 2029
    Reason
    Mnf data change
  • 1000316916 Active Amended

    Technical documentation EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    23 Jul 2026
    Expires
    13 Nov 2029
    Reason
    Mnf data change

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
ALN Optional Vena Cava Filter with Hook EUDAMED
ALN Optional Vena Cava Filter - Jugular Approach with Hook GUDID
Generic Name
Vena cava filter, temporary/permanent
Device Name
ALN Optional Vena Cava Filter
Model / Reference
FJ.HOOK
Primary DI / UDI-DI
03760017680059
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
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K163699)

Other devices from A.L.N.

Properties

  • 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