Identity
- Trade Name
- RS-OIL ECS 5000 EUDAMED
- Device Name
- RS-OIL ECS 5000 EUDAMED
- Model / Reference
- RSO 007-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08021118000098 EUDAMED
- Basic UDI-DI
- B-08021118000098 EUDAMED
- EMDN Code
- Q02030202 OPHTHALMIC SURGERY, SILICONE OILS, PURE AND COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rs-Oil Ecs 5000 by Al.chi.mi.a. S.r.l. — 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-08021118000098 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Al.chi.mi.a. S.r.l.
- EUDAMED SRN
- IT-MF-000028901
Sources (1)
- EUDAMED e66fb47a-d09d-474e-89c8-163a00630b0f 61 fields · synced Jun 19, 2026