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neoprobe NPCU4

by Devicor Medical Products, Inc.

Ref NPCU4

neoprobe NPCU4 is a hand-held-detector nuclear medicine system (EU MDD Class IIa; FDA Class I; FDA product code IZD, Probe, Uptake, Nuclear) made by Devicor Medical Products, Inc., registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-00841911102274) and listed in FDA GUDID since 13 May 2019 (UDI-DI 00841911102274), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841911102274 Basic UDI-DI 00841911102274UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841911102274 UDI-DI Date13 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841911102274 registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00841911102274 listed 13 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841911102274
  2. Registered EUDAMED B-00841911102274

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Neoprobe® Gamma Detection System EUDAMED
neoprobe GUDID
Generic name
Hand-held-detector nuclear medicine system
Device name
Control Unit
Model / Ref / Catalog
NPCU4
Primary DI / UDI-DI
00841911102274
Basic UDI-DI
B-00841911102274
FDA product code
IZD
EMDN code
Z129099 Various instruments for functional exploration and therapeutic interventions - other
GMDN term
Hand-held-detector nuclear medicine system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
892.1320
EU registration type
Legacy device (under a directive)
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 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 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER.

Other devices from Devicor Medical Products, Inc.

See all devices from Devicor Medical Products, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)