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SenSight™ B31030-S

by Medtronic, Inc.

Ref B31030-S

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

CE MDR

Valid until

16 Dec 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00199150032402 UDI-DI Date28 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberG70 039709 1513 Date10 Aug 2026IssuedStatusActive expires 16 Dec 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 039709 1513 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    10 Aug 2026
    Expires
    16 Dec 2029
    Reason
    Add device or group

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  • Withdrawn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
SenSight™
Generic Name
Subcutaneous tunneller, single-use
Device Name
SenSight™ Extension Tunneler Kit
Model / Reference
B31030-S
Primary DI / UDI-DI
00199150032402, 00199150032419
Basic UDI-DI
0763000B00024507X
FDA Product Code
HAO
EMDN Code
J020180 Cerebral implantable neurostimulators - accessories
GMDN Term
Subcutaneous tunneller, single-use
Device Class
Class III EUDAMED
Class I GUDID
Regulation Number
882.4535
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class I

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No