← Back to catalogue
Capsule Polisher 23G, side port, angled 4mm
EUDAMEDClass IIa (EU MDR)
Ref 6001-4Model Capsule Polishers
Identity
- Trade Name
- Capsule Polisher 23G, side port, angled 4mm EUDAMED
- Model / Reference
- Capsule Polishers EUDAMED6001-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516105574 EUDAMED
- Basic UDI-DI
- 0840516160005B 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
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Capsule Polisher 23G, side port, angled 4mm by Psi/Eye-Ko, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- I/A HDP. 45 W SLEEVE 1.8 12/BX — Bausch & Lomb, Inc. · Class II
- Visitec® — Beaver-Visitec International, Inc. · Class I
- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- SURGISTAR — Surgistar Inc. · Class I
- Lasik Irrigator - 4 Ports — Hurricane Medical · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Ophthalmic Cannula — Katena Products, 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 | 0840516160005B | 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 e1768134-6b36-4846-bed7-96bead8d0473 61 fields · synced Aug 4, 2026