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Confida™ GWBC30

by Medtronic, Inc.

Ref GWBC30

Confida™ GWBC30 is a device classified as Class III in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 20 May 2026 (Basic UDI-DI 0763000B000226786) with CE/MDR certificate 2266996TD03 valid until 1 Nov 2028, cleared under FDA 510(k) K181001 on 3 May 2018 and listed in FDA GUDID since 3 Jun 2024 (UDI-DI 00763000758646), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

1 Jun 2028

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

2 certificates

Certifier DEKRA Certification B.V.

510(k) K181001

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000226786 Basic UDI-DI 00763000758646UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000758646 UDI-DI Date3 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181001 Date3 May 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000226786 registered 20 May 2026 Active· +2 more in the status table
  • FDA 510(k) K181001 decided 3 May 2018 Active
  • FDA GUDID UDI-DI 00763000758646 listed 3 Jun 2024 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2266996TD03 Active Amended

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    22 Nov 2023
    Expires
    1 Nov 2028
    Reason
    Other
  • 2266996CE03 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    13 Nov 2023
    Expires
    1 Jun 2028

Timeline

7 dated events

  1. Cleared FDA 510(k) K181001
  2. Certificate issued EUDAMED 2266996CE03
  3. Certificate issued EUDAMED 2266996TD03
  4. Listed FDA GUDID 00763000758646
  5. Registered EUDAMED 0763000B000226786
  6. Certificate expires EUDAMED 2266996CE03
  7. Certificate expires EUDAMED 2266996TD03

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Confida™
Generic name
Cardiac/peripheral vascular guidewire, single-use
Device name
Confida™ Brecker Guidewire
Model / reference
GWBC30
Primary DI / UDI-DI
00763000758646
Basic UDI-DI
0763000B000226786
510(k) Number
FDA product code
DQX
EMDN code
C0499 Cardiovascular guidewires - other
GMDN term
Cardiac/peripheral vascular guidewire, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1330
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 260.0 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cardiac/peripheral vascular guidewire, single-use

Cleared under the same submission (K181001)

Similar devices in this category

Other devices filed under CARDIOVASCULAR GUIDEWIRES - OTHER.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Lot / batch number
Other properties (21, all answered No)