Identity
- Trade Name
- Optima CT660 EUDAMED
- Device Name
- Optima CT660 EUDAMED
- Model / Reference
- Optima CT660 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-OptimaCT660WA EUDAMED
- Basic UDI-DI
- B-OptimaCT660WA EUDAMED
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optima CT660 by GE Healthcare Japan Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-OptimaCT660WA | Class IIb | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Japan Corporation
- EUDAMED SRN
- JP-MF-000009291
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 933f1c2b-5cd1-4f0b-ac30-eb837cd8758b 61 fields · synced Jun 18, 2026