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Irrigating Cystotome 27g X 16mm (5/8"), reverse formed
EUDAMEDClass IIa (EU MDR)
Ref 5001ARFModel Irrigating Cystotomes and Capsulorhexis Cystotomes
Identity
- Trade Name
- Irrigating Cystotome 27g X 16mm (5/8"), reverse formed EUDAMED
- Model / Reference
- Irrigating Cystotomes and Capsulorhexis Cystotomes EUDAMED5001ARF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516105260 EUDAMED
- Basic UDI-DI
- 08405161500054 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
Irrigating Cystotome 27g X 16mm (5/8"), reverse formed by Psi/Eye-Ko, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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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 | 08405161500054 | 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 e64dc36b-1ed1-4953-a18d-27d6511d1f1d 61 fields · synced Jul 18, 2026