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Tri Flat Drill Bit 8530638

by Medtronic, Inc.

Ref 8530638

Tri Flat Drill Bit 8530638 is a device classified as Class IIa in the EU and Class I in the US made by Medtronic, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 0763000B00014768A) and listed in FDA GUDID since 29 Sep 2022 (UDI-DI 00763000654276), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00014768A Basic UDI-DI 00763000654276UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000654276 UDI-DI Date29 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00014768A registered 26 Oct 2026 Active
  • FDA GUDID UDI-DI 00763000654276 listed 29 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00763000654276
  2. Registered EUDAMED 0763000B00014768A

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  • Withdrawn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
Centerpiece™ EUDAMED
Tri Flat Drill Bit GUDID
Generic name
Fluted surgical drill bit, reusable
Device name
Drill Bit 8530637 Drill 1.3mm X 7mm
Model / reference
8530638
Primary DI / UDI-DI
00763000654276
Basic UDI-DI
0763000B00014768A
FDA product code
LXH
EMDN code
P091303 Orthopaedic implant drill bits, single-use
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Fluted surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)