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25g Cannula Cortex
EUDAMEDClass IIa (EU MDR)
Ref 3008Model I/A Cannulas and Cortex Removal
Identity
- Trade Name
- 25g Cannula Cortex EUDAMED
- Model / Reference
- I/A Cannulas and Cortex Removal EUDAMED3008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516104997 EUDAMED
- Basic UDI-DI
- 0840516130004N EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
25g Cannula Cortex by Psi/Eye-Ko, Inc. — 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 | 0840516130004N | Class IIa | Active |
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Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED af201145-7274-4ccb-aae2-bafc23481b91 61 fields · synced Jun 19, 2026