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Midas Rex MR8 IRD870

by Medtronic Powered Surgical Solutions

Ref IRD870

Midas Rex MR8 IRD870 is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 0763000B000203279), cleared under FDA 510(k) K183515 on 12 May 2019 and listed in FDA GUDID since 21 Jul 2025 (UDI-DI 00763000722418), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183515

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 Number0763000B000203279 Basic UDI-DI 00763000722418UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000722418 UDI-DI Date21 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183515 Date12 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000203279 registered 20 Oct 2026 Active
  • FDA 510(k) K183515 decided 12 May 2019 Active
  • FDA GUDID UDI-DI 00763000722418 listed 21 Jul 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183515
  2. Listed FDA GUDID 00763000722418
  3. Registered EUDAMED 0763000B000203279

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  • Withdrawn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 MR8
Generic name
Surgical irrigation tubing set, single-use
Device name
ENTMR8 Irrigation Tubing
Model / reference
IRD870
Primary DI / UDI-DI
00763000722418
Basic UDI-DI
0763000B000203279
510(k) Number
FDA product code
HBE, ERL, HBC, HBB, HXZ
EMDN code
Z12100985 Instruments for motorised neurosurgery systems - consumables
GMDN term
Surgical irrigation tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310, 874.4250, 882.4360, 882.4370, 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 II

Device class is stated on each registry's own scale: Class IIa 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: Surgical irrigation tubing set, single-use

Cleared under the same submission (K183515)

and 8 more cleared under K183515

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)