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Nichamin Hydrodissection Cannula 25g, formed
EUDAMEDClass IIa (EU MDR)
Ref 7021LModel Nucleus Removal, Irrigating, Hydrodissection & Hydrodelineation
Identity
- Trade Name
- Nichamin Hydrodissection Cannula 25g, formed EUDAMED
- Model / Reference
- Nucleus Removal, Irrigating, Hydrodissection & Hydrodelineation EUDAMED7021L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516106007 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
Nichamin Hydrodissection Cannula 25g, formed 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 |
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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 2a61ac7e-6ec7-44e9-be66-048bbe5cc7f2 61 fields · synced Jun 19, 2026