Identity
- Trade Name
- 21G straight I/A tip with silicone sleeve EUDAMED
- Device Name
- EasySys cassette kit EUDAMED
- Model / Reference
- 114218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059308009170 EUDAMED
- Basic UDI-DI
- 8059308SUR_IAC_021MT EUDAMED
- EMDN Code
- L1713 OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
21G straight I/A tip with silicone sleeve by Optikon 2000 S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable.
- HESLIN INFUSION CANNULA — SONTEC INSTRUMENTS, INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- PANNU VISCO ASPIRATING CANNULA 22/23GA — Katena Products, Inc. · Class I
- Appasamy — APPASAMY ASSOCIATES PRIVATE LIMITED · Class IIa
- MR PHACO — Crestpoint Management Ltd. · Class I
- Mclntyre Anterior Chamber Cannula Angled Gauge 30 Stainless Steel — SURTEX INSTRUMENTS LTD · Class IIa
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
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_IAC_021MT | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Optikon 2000 S.p.A.
- EUDAMED SRN
- IT-MF-000017618
Sources (1)
- EUDAMED 2ab442b1-4c97-4d57-9ee8-bdca4143891d 61 fields · synced Jun 19, 2026