Identity
- Trade Name
- autofusion EUDAMED
- Device Name
- autofusion EUDAMED
- Model / Reference
- OCT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664188000596 EUDAMED
- Basic UDI-DI
- 13664188000596MU EUDAMED
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
autofusion by Luneau Technology Operations — Class IIa — 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 | 13664188000596MU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Luneau Technology Operations
- EUDAMED SRN
- FR-MF-000009091
Sources (1)
- EUDAMED 702e47e3-c306-4384-8aa8-cd62dce3dee0 61 fields · synced Jul 30, 2026