Identity
- Trade Name
- REVOLUTION ASPIRE EUDAMED
- Model / Reference
- REVOLUTION ASPIRE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278670533 EUDAMED
- Basic UDI-DI
- 8406821BUG00276HP EUDAMED
- EMDN Code
- Z11030603 COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS 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 Aspire by Wipro GE Medical Device manufacturing Private Limited — 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 | 8406821BUG00276HP | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- IN-MF-000045781
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED f214b58f-69c3-4cc2-8f8b-8c38ba94c5ea 61 fields · synced Oct 6, 2026