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Guardian™ 6015

by St. Jude Medical, Inc.

Ref 6015

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

CE MDR

Valid until

19 Dec 2026

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 Number5415067DBS0001BQ Basic UDI-DI 05415067030290UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067030290 UDI-DI Date24 Aug 2018ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 744775 Expiring Supplemented Expires in 47 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    4 Aug 2026
    Expires
    19 Dec 2026
    Reason
    Other

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  • Withdrawn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 Expiring
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Guardian™
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device Name
Deep Brain Stimulation
Model / Ref / Catalog
6015
Primary DI / UDI-DI
05415067030290
Basic UDI-DI
5415067DBS0001BQ
510(k) Number
FDA Product Code
GXR
EMDN Code
J020180 Cerebral implantable neurostimulators - accessories
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
882.5250
EU market of registration
Belgium
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

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K181382)

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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