Identity
- Trade Name
- 21G straight phaco tip, 30° EUDAMED
- Device Name
- 22G flared phaco tip, 30° EUDAMED
- Model / Reference
- 191213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308009361 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
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
21G straight 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 (1)
- EUDAMED 7a7a37e3-79e8-4a7a-8367-a179769fc40d 61 fields · synced Jun 19, 2026