Identity
- Trade Name
- Optistar EUDAMED
- Device Name
- Optistar EUDAMED
- Model / Reference
- 814006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10746190005988 EUDAMED
- Basic UDI-DI
- 0746190L000025N EUDAMED
- EMDN Code
- Z11059001 MAGNETIC RESONANCE 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
Optistar by Liebel-Flarsheim Company, LLC — 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 | 0746190L000025N | 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 (1)
- EUDAMED 5c51a94d-64f5-42f5-aab1-294a64e8a1b4 61 fields · synced Oct 6, 2026