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Gammapro Std

by General Equipment for Medical Imaging, S.A.

Ref IC-1150Model STD, LAP, HI-S

Gammapro Std (IC-1150) is a medical device (EU MDR Class IIa; FDA Class I; FDA product code IZD, Probe, Uptake, Nuclear; EMDN category beta/gamma detectors) made by General Equipment for Medical Imaging, S.A., registered in EUDAMED on 30 Nov 2021 (Basic UDI-DI 8437018413GAMMAPROBE7U) and listed in FDA GUDID since 1 Dec 2021 (UDI-DI 08437018413072), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08437018413072 UDI-DI Date1 Dec 2021ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8437018413GAMMAPROBE7U Basic UDI-DI 08437018413072UDI-DIDate30 Nov 2021RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8437018413GAMMAPROBE7U registered 30 Nov 2021 Active
  • FDA GUDID UDI-DI 08437018413072 listed 1 Dec 2021 Listed

Timeline

2 dated events

  1. Registered EUDAMED 8437018413GAMMAPROBE7U
  2. Listed FDA GUDID 08437018413072

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  • Withdrawn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
Gammapro Std EUDAMED
Wprobe GUDID
Generic name
Intraoperative gamma radiation detection system probe, reusable
Model / Ref / Catalog
STD, LAP, HI-S, IC-1150
Primary DI / UDI-DI
08437018413072
Basic UDI-DI
8437018413GAMMAPROBE7U
Direct marketing DI
08437018413072
FDA product code
IZD
EMDN code
Z11029001 Beta/gamma detectors
GMDN term
Intraoperative gamma radiation detection system probe, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
892.1320
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Hydrogen Peroxide
Size
Length — 255 Millimeter
Weight — 162 Gram
Width — 40 Millimeter
Height — 40 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
STD, LAP, HI-S
IC-1150
GUDID
STD
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.

Manufacturer details

EUDAMED SRN
ES-MF-000013779

Related devices

Category: Hand-held-detector nuclear medicine system

Similar devices in this category

Other devices filed under BETA/GAMMA DETECTORS.

Other devices from General Equipment for Medical Imaging, S.A.

See all devices from General Equipment for Medical Imaging, S.A. →

Properties

  • Sterilise before use
  • Reusable
  • Measuring function
  • Prescription use
  • Combination product
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)