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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
- 00840516145310 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
No
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
Capsule Polisher 23G, side port, angled 4mm 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 | 0840516160005B | 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 32719c77-56ea-47d3-8c1b-588a24627ed1 61 fields · synced Jul 12, 2026