Identity
- Trade Name
- Optivantage EUDAMEDOptiVantage Dual-Head CT Contrast Delivery System EUDAMED
- Device Name
- Optivantage Dual-Head CT Contrast Delivery System EUDAMEDOptiVantage EUDAMED
- Model / Reference
- 844009 EUDAMED849102 EUDAMED849101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10746190002840 EUDAMED10746190005919 EUDAMED10746190005902 EUDAMED
- Basic UDI-DI
- B-10746190002840 EUDAMED0746190L000035Q EUDAMED
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Optivantage by Liebel-Flarsheim Company, LLC — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-10746190002840 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-10746190002840 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Liebel-Flarsheim Company, LLC
- EUDAMED SRN
- US-MF-000002605
- Authorised Representative
- Guerbet FR-AR-000000812
Sources (3)
- EUDAMED 3eb10673-1184-4d76-abb0-91bb011db822 61 fields · synced Oct 6, 2026
- EUDAMED 333cb455-283b-4a41-a177-4fbfa506374d 61 fields · synced May 17, 2026
- EUDAMED bd56ae1c-d86c-4585-a80d-dea5b490e1ea 61 fields · synced May 18, 2026