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IRRIGATION/ ASPIRATION INSTRUMENTS(Flute needle)
EUDAMEDClass I (EU MDR)
Ref 23-CP006048Ref 23-CP006058Ref 23-CP006008Ref 23-CP006056Ref 23-CP006036Ref 23-CP006043
Identity
- Trade Name
- IRRIGATION/ ASPIRATION INSTRUMENTS(Flute needle) EUDAMED
- Device Name
- IRRIGATION/ ASPIRATION INSTRUMENTS EUDAMED
- Model / Reference
- 23-CP006048 EUDAMED23-CP006058 EUDAMED23-CP006008 EUDAMED23-CP006056 EUDAMED23-CP006036 EUDAMED23-CP006043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974957364130 EUDAMED06974957362716 EUDAMED06974957361245 EUDAMED06974957364147 EUDAMED06974957361252 EUDAMED06974957362723 EUDAMED
- Basic UDI-DI
- 697495736ED006KK EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
IRRIGATION/ ASPIRATION INSTRUMENTS(Flute needle) by Gaush Precision Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar 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 | 697495736ED006KK | Class I | Active |
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Manufacturer
- Manufacturer
- Gaush Precision Ltd
- EUDAMED SRN
- CN-MF-000028969
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (6)
- EUDAMED 0f456f08-4d16-4507-89a9-5e5df2f43416 61 fields · synced Sep 30, 2026
- EUDAMED 83ef050a-23dc-4b99-b583-8252aac233c0 61 fields · synced May 17, 2026
- EUDAMED 78763c79-21d3-4e84-ab6a-db0592d806af 61 fields · synced May 17, 2026
- EUDAMED 67ba9641-ebeb-480c-abc8-13f5a24e7572 61 fields · synced May 17, 2026
- EUDAMED 8bc97413-784b-4b9b-8809-f9ccac3275ad 61 fields · synced May 17, 2026
- EUDAMED 7914d36b-fc1b-4269-a767-178a4aa2b9a8 61 fields · synced May 19, 2026