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Microdeep Depth Electrode (15 contacts)

by DIXI Medical France EUDAMED510(k)GUDID

Ref D08-15AMModel Microdeep Depth Electrode

Product code GZLEMDN N0101020102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03664539000091 Basic UDI-DIDate13 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number03664539000091 UDI-DIDate14 Dec 2017ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK170959 Date24 Nov 2017IssuedStatusActive

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
  • Expiring (legacy directive)
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-0535-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0542-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0541-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0540-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0538-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0537-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0536-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0534-2022 FDA Class II initiated 9 Dec 2021
    • Terminated Z-0539-2022 FDA Class II initiated 9 Dec 2021

    Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
Microdeep Depth Electrode (15 contacts) EUDAMED
Na GUDID
Generic Name
Depth electrode
Model / Ref / Catalog
Microdeep Depth Electrode, D08-15AM
Primary DI / UDI-DI
03664539000091
Basic UDI-DI
B-03664539000091
510(k) Number
FDA Product Code
GZL
EMDN Code
N0101020102 EEG depth electrodes
GMDN Term
Depth electrode
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
882.1330
Market of Registration
France
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000005237

Other devices from Dixi Medical

See all devices from Dixi Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Serial Number
  • Expiration Date
Other properties (17)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Lot / Batch Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 19d57532-66ca-4786-803d-fa7b39ab2a22 61 fields · synced 24 Oct 2026
  • FDA UDI 23c3f410-83a0-478e-974d-70fcddb97f03 37 fields · synced 30 May 2026
  • FDA 510(k) K170959 1 fields · synced 18 May 2026