Identity
- Trade Name
- KIT PHACO FULL 21/FLB 2ST EUDAMED
- Device Name
- KIT PHACO FULL 21/30 2STW EUDAMED
- Model / Reference
- 19510Z EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308004397 EUDAMED
- Basic UDI-DI
- 8059308KIT_PHC_043BH EUDAMED
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE 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
Kit Phaco Full 21/Flb 2st 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 | 8059308KIT_PHC_043BH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED 1fe94928-b864-4bfe-8761-93633021185e 61 fields · synced Jun 18, 2026