← Back to catalogue
Cortical Cleaving Hydrodissector 25g
EUDAMEDClass IIa (EU MDR)
Ref 7016AModel Nucleus Removal, Irrigating, Hydrodissection & Hydrodelineation
Identity
- Trade Name
- Cortical Cleaving Hydrodissector 25g EUDAMED
- Model / Reference
- Nucleus Removal, Irrigating, Hydrodissection & Hydrodelineation EUDAMED7016A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516105949 EUDAMED
- Basic UDI-DI
- 0840516170005J 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
Cortical Cleaving Hydrodissector 25g 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 | 0840516170005J | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 189b5a5f-d05c-46c0-b87f-b3420b2e7718 61 fields · synced Jul 26, 2026