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Mammi Compact Dr
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref FP-0205Model MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN
Identity
- Trade Name
- MAMMI COMPACT DR EUDAMED
- Model / Reference
- MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN EUDAMEDFP-0205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437018413065 EUDAMED
- Basic UDI-DI
- 8437018413DEDICATEDPETJD EUDAMED
- Direct Marketing DI
- 08437018413065 EUDAMED
- EMDN Code
- Z11020401 POSITRON EMISSION TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Mammi Compact Dr by General Equipment For Medical Imaging, S.a. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232569 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161631 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K140996 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8437018413DEDICATEDPETJD | Class IIa | Active |
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Manufacturer
- Manufacturer
- General Equipment For Medical Imaging, S.a.
- EUDAMED SRN
- ES-MF-000013779
Sources (2)
- EUDAMED 4745097b-bf8a-494b-812b-887908f633e5 61 fields · synced Jul 17, 2026
- FDA 510(k) K232569 1 fields · synced May 18, 2026