Identity
- Trade Name
- PHACO HANDPIECE "SLIM 4" EUDAMED
- Device Name
- PHACO HANDPIECE "SIX" EUDAMED
- Model / Reference
- 113101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308000139 EUDAMED
- Basic UDI-DI
- 8059308SUR_HPC_025TM EUDAMED
- EMDN Code
- L1710 EYE SURGERY HANDPIECES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Phaco Handpiece "slim 4" by Optikon 2000 S.p.A. — 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 | 8059308SUR_HPC_025TM | Class IIb | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED 0de5ec4f-043f-4d98-bf02-40a3544f8be0 61 fields · synced Jul 10, 2026