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neoprobe NPB09S

by Devicor Medical Products, Inc.

Ref NPB09S

neoprobe NPB09S 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 23 Sep 2026 (Basic UDI-DI B-00841911102557) and listed in FDA GUDID since 10 Nov 2016 (UDI-DI 00841911102557), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841911102557 Basic UDI-DI 00841911102557UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841911102557 UDI-DI Date10 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841911102557 registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00841911102557 listed 10 Nov 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841911102557
  2. Registered EUDAMED B-00841911102557

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  • Withdrawn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
Bluetooth Wireless Probe - Straight
Model / Ref / Catalog
NPB09S, CA000539001
Primary DI / UDI-DI
00841911102557, 00841911100263
Basic UDI-DI
B-00841911102557
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
MRI safety
MR Unsafe

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Supplied sterileEUDAMED
No
GUDID
No
Yes
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

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

  • Supplied sterile UDI-DI 00841911102557: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 00841911102557: EUDAMED states Yes, FDA GUDID states No.

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

  • Supplied sterile NoEUDAMEDGUDIDYesGUDID
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use NoGUDIDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number NoGUDIDYesGUDID
  • Serial number
  • Expiration date NoGUDIDYesGUDID
  • Manufacturing date
Other properties (16, all answered No)