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Mammi Dr
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FP-0203Model MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN
Identity
- Trade Name
- MAMMI DR EUDAMEDMAMMI FDA UDI
- Generic Name
- PET system FDA UDI
- Device Name
- MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities: - Breast PET Mammography System with a single ring detector and a prone examination bed. - Breast PET Mammography System with a double ring detector and a prone examination bed (this record). FDA UDI
- Model / Reference
- MAMMI SR, MAMMI DR, MAMMI COMPACT SR, MAMMI COMPACT DR, CAREMIBRAIN EUDAMEDFP-0203 EUDAMEDMAMMI DR FDA UDI
- Description
- MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities: - Breast PET Mammography System with a single ring detector and a prone examination bed. - Breast PET Mammography System with a double ring detector and a prone examination bed (this record). FDA UDI
Identifiers
- Catalog Number
- FP-0203 FDA UDI
- Primary DI / UDI-DI
- 08437018413041 EUDAMEDFDA UDI
- Basic UDI-DI
- 8437018413DEDICATEDPETJD EUDAMED
- Direct Marketing DI
- 08437018413041 EUDAMED
- 510(k) Number
- K161631 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020401 POSITRON EMISSION TOMOGRAPHS EUDAMED
- GMDN Term
- PET system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- Spain EUDAMED
- 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 — 1480 Millimeter FDA UDILength — 1430 Micrometer FDA UDIWidth — 661 Millimeter FDA UDIWeight — 160 Kilogram FDA UDI
Mammi Dr 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8437018413DEDICATEDPETJD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- General Equipment For Medical Imaging, S.a.
- EUDAMED SRN
- ES-MF-000013779
Sources (2)
- EUDAMED 167ec6ae-dbbb-4c88-b00d-628368adf822 61 fields · synced Jul 10, 2026
- FDA UDI 2b107f0e-3257-4d36-8495-bab49efb6741 37 fields · synced May 30, 2026