Identity
- Trade Name
- PACK IVT EUDAMED
- Device Name
- Assemblage OPHTALMOLOGIE STE EUDAMEDAssemblage OPHTALMOLOGIE NON STE EUDAMED
- Model / Reference
- SE9667_2 EUDAMED9667_1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661379260494 EUDAMED03661379259368 EUDAMED
- Basic UDI-DI
- 3661379ASS39OPH01R2 EUDAMED3661379ASS38OPH2ARR EUDAMED
- EMDN Code
- Q02030299 OPHTHALMOLOGY, LIQUID FLUIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Medical Purpose
- Les assemblages de la gamme ‘Ophtalmologie’ sont destinés à : Être utilisés lors des examens et traitements des affections des yeux et des troubles de la vision. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Pack Ivt by Hemodia Sas — Class I — 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 | 3661379ASS39OPH01R2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hemodia Sas
- EUDAMED SRN
- FR-PR-000007189
Sources (2)
- EUDAMED fc67946b-9227-499f-8d38-4e45f106f476 61 fields · synced Jul 16, 2026
- EUDAMED 74213c17-6868-4898-b39a-4ba2896895b4 61 fields · synced May 17, 2026