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neoprobe CA000537001

by Devicor Medical Products, Inc.

Ref NPB11L

neoprobe CA000537001 (NPB11L) 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-00841911102540) and listed in FDA GUDID since 16 Sep 2024 (UDI-DI 00841911102540), 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-00841911102540 Basic UDI-DI 00841911102540UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841911102540 UDI-DI Date16 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841911102540 registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00841911102540 listed 16 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841911102540
  2. Registered EUDAMED B-00841911102540

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  • Withdrawn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 Laparoscopic Probe
Model / Ref / Catalog
NPB11L, CA000537001
Primary DI / UDI-DI
00841911102540
Basic UDI-DI
B-00841911102540
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 · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
NPB11L
GUDID
CA000537001
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

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

  • Sterilise before use UDI-DI 00841911102540: 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

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)