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Revolution Apex Elite
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 5590000-23Model Revolution
Identity
- Trade Name
- Revolution Apex Elite EUDAMEDRevolution FDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- Revolution Apex Elite - Designated System Medical Device FDA UDI
- Model / Reference
- Revolution EUDAMED5590000-23 EUDAMEDApex Elite FDA UDI
- Description
- Revolution Apex Elite - Designated System Medical Device FDA UDI
Identifiers
- Catalog Number
- 5590000-23 FDA UDI
- Primary DI / UDI-DI
- 00195278460271 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00014GP EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030607 COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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
Revolution Apex Elite by Ge Medical Systems, Inc. — Class IIb — 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 | 8406821BUG00014GP | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED f64a5a64-8bc1-4ebb-973a-cee01d8973fb 61 fields · synced Jun 18, 2026
- FDA UDI e6a85e68-6f6c-4c03-bec0-c8b7ac7c4199 34 fields · synced May 30, 2026