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MU2net

by Dosisoft

Ref MU1001

MU2net (MU1001) is a Class I device made by Dosisoft, registered in EUDAMED on 23 Nov 2021 (Basic UDI-DI B-+B501MU2NET0201010) and cleared under FDA 510(k) K191944 on 24 Oct 2019, active as of 25 Oct 2026.

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191944↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+B501MU2NET0201010 Basic UDI-DI +B501MU2NET0201010UDI-DIDate23 Nov 2021RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK191944 Date24 Oct 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+B501MU2NET0201010 registered 23 Nov 2021 Active
  • FDA 510(k) K191944 decided 24 Oct 2019 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K191944
  2. Registered EUDAMED B-+B501MU2NET0201010

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
MU1001
Primary DI / UDI-DI
+B501MU2NET0201010
Basic UDI-DI
B-+B501MU2NET0201010
EMDN code
Z11019092 Various radiotherapy and radiosurgery instruments - medical device software
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014706

Similar devices in this category

Other devices filed under VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS.

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Properties

Other properties (12, all answered No)