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Sterile Heavy Liquid Infusion Cannulae.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 4477-02/YModel Heavy Liquid Infusion Cannulae Ref M4499A-02/10
Identity
- Trade Name
- Heavy Liquid Infusion Cannulae FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Sterile Heavy Liquid Infusion Cannulae. EUDAMEDHeavy Liquid Infusion Cannulae EUDAMED25g Perfluorocarbon FDA UDI
- Model / Reference
- Heavy Liquid Infusion Cannulae EUDAMED4477-02/Y EUDAMEDM4499A-02/10 EUDAMEDFDA UDI
- Description
- 25g Perfluorocarbon FDA UDI
Identifiers
- Catalog Number
- M4499A FDA UDI
- Primary DI / UDI-DI
- 15056030401449 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560304F11-DXL EUDAMEDB-15056030401449 EUDAMED
- FDA Product Code
- MED FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6885 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Sterile Heavy Liquid Infusion Cannulae. by Sterimedix Ltd — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 50560304F11-DXL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 50560304F11-DXL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sterimedix Ltd
- EUDAMED SRN
- GB-MF-000011604
- Authorised Representative
- Bausch & Lomb GmbH DE-AR-000006810
Sources (3)
- EUDAMED b1c1df20-ca3a-4306-80cf-4f926814e8f1 61 fields · synced Jul 9, 2026
- EUDAMED 9151316a-ce65-4981-9887-c490837358b5 61 fields · synced May 19, 2026
- FDA UDI d5de5e88-eef6-4307-bd4b-94c154353822 34 fields · synced May 30, 2026