MAMMOMAT Revelation
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MAMMOMAT Revelation EUDAMEDFDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- MDR_18_II b_ERLN H 127_Mammo_digital EUDAMED
- Model / Reference
- 11343300 EUDAMEDFDA UDIMDR_18_II b_ERLN H 127_Mammo_digital EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869124575 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901979WW EUDAMED
- FDA Product Code
- MUE FDA UDI
- EMDN Code
- Z11030202 DIGITAL MAMMOGRAPHY SYSTEMS EUDAMED
- GMDN Term
- Stationary mammographic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1715 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Stationary mammographic x-ray system, digital
MAMMOMAT Revelation by Siemens Healthcare — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Stationary mammographic x-ray system, digital.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare
Sources (2)
- FDA UDI c5f78f1d-8b5e-4f23-8715-401fe3c7045b 34 fields · synced Jul 17, 2026
- EUDAMED 7ebddf89-7006-4b4f-98a3-83747532c03f 61 fields · synced Jul 17, 2026