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Certificate Number: CE 674211
Scope: The design, development and manufacture of:
Sterile and non-sterile rectal catheters for use in urodynamics;
Sterile bladder catheters, for use in urology and urodynamics;
Sterile and non-sterile administration sets, for use in urology, urodynamics and theatres;
Sterile total intravenous anaesthesia (TIVA) sets, extension sets and peripheral connectors, for use within anaesthesiology, surgery, recovery and obstetrics;
Sterile vascular ligation/occlusion loops, for use in surgery;
Oxygen masks and Capnomasks, for oxygen delivery and monitoring of end tidal carbon dioxide;
Non-sterile Silicone Shelf Pessary, for use in gynaecology;
Sterile Silicone, 3 way catheter, for use in urology.
| Original Registration Date | Effective Date | Last Revision Date | Expiry Date |
|---|---|---|---|
| 2018-01-08 | 2021-01-07 | 2024-05-26 |