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Midas Rex EA120

by Medtronic Powered Surgical Solutions

Ref EA120

Midas Rex EA120 is a device classified as Class I in the EU and Class II in the US made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0763000B000015072), cleared under FDA 510(k) K081277 on 5 Sep 2008 and listed in FDA GUDID since 2 Oct 2020 (UDI-DI 00763000374754), active as of 7 Nov 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081277

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000015072 Basic UDI-DI 00763000374754UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000374754 UDI-DI Date2 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK081277 Date5 Sep 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000015072 registered 25 Sep 2026 Active
  • FDA 510(k) K081277 decided 5 Sep 2008 Active
  • FDA GUDID UDI-DI 00763000374754 listed 2 Oct 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0961-2022 FDA Class II initiated 15 Dec 2021

    As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that resulted in a difference between the set number of rotations and the actual number of rotations in a specific mode when the product was used with our company's M5 handpiece.

Timeline

4 dated events

  1. Cleared FDA 510(k) K081277
  2. Listed FDA GUDID 00763000374754
  3. Recall initiated FDA recalls Z-0961-2022
  4. Registered EUDAMED 0763000B000015072

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
Midas Rex
Generic name
Instrument tray, reusable
Device name
Case CA800 MR8 Instrument 1/2 Din
Model / reference
EA120
Primary DI / UDI-DI
00763000374754
Basic UDI-DI
0763000B000015072
510(k) Number
FDA product code
ERL
EMDN code
L80 Surgical instruments, reusable - various accessories
GMDN term
Instrument tray, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4250
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00763000374754: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I 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: Instrument tray, reusable

Cleared under the same submission (K081277)

and 8 more cleared under K081277

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)