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Lacrimal Cannula 21g X 28mm (1 1/8"), curved
EUDAMEDClass IIa (EU MDR)
Ref 8000-21Model Lacrimal cannulas
Identity
- Trade Name
- Lacrimal Cannula 21g X 28mm (1 1/8"), curved EUDAMED
- Model / Reference
- Lacrimal cannulas EUDAMED8000-21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516106045 EUDAMED
- Basic UDI-DI
- 0840516180005R 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
Lacrimal Cannula 21g X 28mm (1 1/8"), curved 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 | 0840516180005R | 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 58c989d0-d09f-4e3b-8ac1-bfbbd146e666 61 fields · synced Oct 6, 2026