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Caremibrain

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref FP-0600Model MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAINRef FP-0204

by General Equipment For Medical Imaging, S.a.

Identity

Trade Name
CAREMIBRAIN EUDAMEDFDA UDI
MAMMI COMPACT SR EUDAMED
Generic Name
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two main parts: the detection and acquisition system and the Control Unit. FDA UDI
Model / Reference
MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN EUDAMED
FP-0600 EUDAMEDFDA UDI
FP-0204 EUDAMED
Description
CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two main parts: the detection and acquisition system and the Control Unit. FDA UDI

Identifiers

Catalog Number
FP-0600 FDA UDI
Primary DI / UDI-DI
08437018413188 EUDAMEDFDA UDI
08437018413058 EUDAMED
Basic UDI-DI
8437018413DEDICATEDPETJD EUDAMED
Direct Marketing DI
08437018413188 EUDAMED
08437018413058 EUDAMED
510(k) Number
K232569 FDA UDI
FDA Product Code
KPS FDA UDI
EMDN Code
Z11020401 POSITRON EMISSION TOMOGRAPHS EUDAMED
GMDN Term
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 1776 Millimeter FDA UDI
Weight — 300 Kilogram FDA UDI
Width — 780 Millimeter FDA UDI
Depth — 203 Millimeter FDA UDI
Length — 2281 Millimeter FDA UDI

Caremibrain by General Equipment For Medical Imaging, S.a. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
General Equipment For Medical Imaging, S.a.
EUDAMED SRN
ES-MF-000013779

Sources (3)

  • EUDAMED 6c0b9a2c-c59f-4e9c-9963-f2119c727f3a 61 fields · synced Aug 2, 2026
  • EUDAMED 35e87045-9e36-4bbc-9b18-6a8dbb2d175e 61 fields · synced May 19, 2026
  • FDA UDI 9a25f03f-8d9b-446f-a390-e3c0ba7bc288 37 fields · synced May 30, 2026