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Sterile Heavy Liquid Infusion Cannulae.
EUDAMEDClass IIa (EU MDR)
Ref M4474-02/10Model Heavy Liquid Infusion Cannulae
Identity
- Device Name
- Sterile Heavy Liquid Infusion Cannulae. EUDAMED
- Model / Reference
- Heavy Liquid Infusion Cannulae EUDAMEDM4474-02/10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35056030401276 EUDAMED
- Basic UDI-DI
- 50560304F11-DXL 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
Sterile Heavy Liquid Infusion Cannulae. by Sterimedix Ltd — 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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- 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-DXL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterimedix Ltd
- EUDAMED SRN
- GB-MF-000011604
- Authorised Representative
- Bausch & Lomb GmbH DE-AR-000006810
Sources (1)
- EUDAMED 550d8138-533f-48a0-bd76-b535f0b1ee8f 61 fields · synced Jul 18, 2026