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TruNode 120-807611

by Hologic

Ref 120-807611

TruNode 120-807611 is a hand-held-detector nuclear medicine system (EU MDR Class IIa; FDA Class I; FDA product code IZD, Probe, uptake, nuclear) made by Hologic, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 54200455TRUNODEBSHD6) and listed in FDA GUDID since 16 Apr 2022 (UDI-DI 15420045514638), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number54200455TRUNODEBSHD6 Basic UDI-DI 15420045514638UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045514638 UDI-DI Date16 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 54200455TRUNODEBSHD6 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 15420045514638 listed 16 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15420045514638
  2. Registered EUDAMED 54200455TRUNODEBSHD6

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  • Withdrawn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
TruNode User Feedback Unit EUDAMED
TruNode GUDID
Generic name
Hand-held-detector nuclear medicine system
Device name
TruNode Gamma Probe System
Model / Ref / Catalog
120-807611
Primary DI / UDI-DI
15420045514638
Basic UDI-DI
54200455TRUNODEBSHD6
Direct marketing DI
15420045514638
FDA product code
IZD
EMDN code
Z11029001 Beta/gamma detectors
GMDN term
Hand-held-detector nuclear medicine system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
892.1320
EU registration type
Standard device
EU market of registration
Belgium
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: Hand-held-detector nuclear medicine system

Similar devices in this category

Other devices filed under BETA/GAMMA DETECTORS.

Other devices from Hologic

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)