← Back to catalogue
Vitreoretinal Cannulae.
EUDAMEDClass IIa (EU MDR)
Ref 4474NS-02Model M4474-02/10Ref M4486-02/10Ref 4474NS-02/YModel 4477NS-02/Y
Identity
- Device Name
- Vitreoretinal Cannulae. EUDAMEDVitreoretinal Cannulae (F11-B) EUDAMED
- Model / Reference
- M4474-02/10 EUDAMED4474NS-02 EUDAMEDM4486-02/10 EUDAMED4477NS-02/Y EUDAMED4474NS-02/Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 65056030401277 EUDAMED25056030402924 EUDAMED15056030401272 EUDAMED
- Basic UDI-DI
- 50560304F11-FXQ EUDAMED50560304F11-BXG 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Vitreoretinal Cannulae. by Sterimedix Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Soft Tip Cannula 20g, 0.8mm tip — Psi/Eye-Ko, Inc. · Class IIa
- 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
- 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 | 50560304F11-FXQ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterimedix Ltd
- EUDAMED SRN
- GB-MF-000011604
- Authorised Representative
- Bausch & Lomb GmbH DE-AR-000006810
Sources (3)
- EUDAMED 1c586600-7995-473e-8c7d-687dfa2a9837 61 fields · synced Jul 10, 2026
- EUDAMED d969e803-817c-408d-b8ac-dd2ebbcbecae 61 fields · synced May 17, 2026
- EUDAMED db951541-c8d8-49f3-bba5-d886264c4e93 61 fields · synced May 19, 2026