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Midas Rex MR8 MR8-TT18MIS

by Medtronic Powered Surgical Solutions EUDAMEDGUDID

Active European Union

Ref MR8-TT18MIS

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00014067M Basic UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000446901 UDI-DIDate19 May 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Midas Rex MR8
Generic Name
Burring power tool attachment
Device Name
MR8 Telescoping Attachment
Model / Reference
MR8-TT18MIS
Primary DI / UDI-DI
00763000446901
Basic UDI-DI
0763000B00014067M
510(k) Number
FDA Product Code
HBE
EMDN Code
Z12100985 Instruments for motorised neurosurgery systems - consumables
GMDN Term
Burring power tool attachment
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4310
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Burring power tool attachment

Cleared under the same submission (K183515)

Show all (12)

Similar devices

Also classified as Burring power tool attachment.

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Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No