Identity
- Trade Name
- 21G flared phaco tip, 30° EUDAMED
- Device Name
- 22G flared phaco tip, 30° EUDAMED
- Model / Reference
- 191216 EUDAMED113241 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308008814 EUDAMED08059308008739 EUDAMED
- Basic UDI-DI
- 8059308SUR_TIP_0263S EUDAMED
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
21G flared phaco tip, 30° by Optikon 2000 S.p.A. — 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 | 8059308SUR_TIP_0263S | Class IIa | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (2)
- EUDAMED 0cecd0e4-a222-435a-88bd-5099ebc72598 61 fields · synced Jul 30, 2026
- EUDAMED 501a573e-f801-4258-832d-7b6a31deb502 61 fields · synced May 18, 2026