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Irrigating Cystotome 27g X 16mm (5/8"), straight
EUDAMEDClass IIa (EU MDR)
Ref 5001ASModel Irrigating Cystotomes and Capsulorhexis Cystotomes
Identity
- Trade Name
- Irrigating Cystotome 27g X 16mm (5/8"), straight EUDAMED
- Model / Reference
- Irrigating Cystotomes and Capsulorhexis Cystotomes EUDAMED5001AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840516105277 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
Irrigating Cystotome 27g X 16mm (5/8"), straight 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 | 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 06f1d987-8579-4a85-b5df-0e988483052d 61 fields · synced Jun 19, 2026