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Mammi Sr

by General Equipment for Medical Imaging, S.A.

Ref FP-0202Model MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN

Mammi Sr (FP-0202) is a PET system (EU MDR Class IIa; FDA Class II; FDA product code KPS, System, Tomography, Computed, Emission) made by General Equipment for Medical Imaging, S.A., registered in EUDAMED on 30 Nov 2021 (Basic UDI-DI 8437018413DEDICATEDPETJD), cleared under FDA 510(k) K161631 on 28 Jul 2016 and listed in FDA GUDID since 14 Jan 2022 (UDI-DI 08437018413034), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161631

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08437018413034 UDI-DI Date14 Jan 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8437018413DEDICATEDPETJD Basic UDI-DI 08437018413034UDI-DIDate30 Nov 2021RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK161631 Date28 Jul 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8437018413DEDICATEDPETJD registered 30 Nov 2021 Active
  • FDA 510(k) K161631 decided 28 Jul 2016 Active
  • FDA GUDID UDI-DI 08437018413034 listed 14 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161631
  2. Registered EUDAMED 8437018413DEDICATEDPETJD
  3. Listed FDA GUDID 08437018413034

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mammi Sr EUDAMED
Mammi GUDID
Generic name
PET system
Model / Ref / Catalog
MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN, FP-0202
Primary DI / UDI-DI
08437018413034
Basic UDI-DI
8437018413DEDICATEDPETJD
Direct marketing DI
08437018413034
510(k) Number
FDA product code
KPS
EMDN code
Z11020401 Positron emission tomographs
GMDN term
PET system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1200
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Size
Weight — 154 Kilogram
Height — 1480 Millimeter
Length — 1430 Millimeter
Width — 661 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN
FP-0202
GUDID
MAMMI SR
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II 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

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Properties

  • Reusable
  • Prescription use
  • Combination product
  • Serial number
Other properties (21, all answered No)