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Revolution UPG 5
EUDAMEDClass IIb (EU MDR)
Ref Revolution UPG 5Model Revolution
Identity
- Trade Name
- Revolution UPG 5 EUDAMED
- Model / Reference
- Revolution EUDAMEDRevolution UPG 5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00198953147481 EUDAMED
- Basic UDI-DI
- 8406821BUG00014GP EUDAMED
- Direct Marketing DI
- 00198953147481 EUDAMED
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Revolution UPG 5 by Ge Medical Systems, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00014GP | Class IIb | Active |
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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 (1)
- EUDAMED 70afc6ba-5c80-42e9-bd3a-9588cf94eca6 61 fields · synced Jun 18, 2026