CMR Surgical Limited
GB-MF-000010885 · United Kingdom · Cambridge
CMR Surgical Limited is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: Insulating Sleeve Accessory, Ultrasonic Dissector Chassis, Ultrasonic Dissector Transducer, Ultrasonic Mode Change Foot Pedal – Long, Ultrasonic Mode Change Foot Pedal – Short.
Among these devices, 16 are declared sterile, 8 reusable, 11 active.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Bedside Unit Cable - Short
- Bipolar Bedside Unit Cable
- Drape Cap Insert
- Monopolar Bedside Unit Cable
- Ultrasonic Mode Change Foot Pedal – Long
- Ultrasonic Mode Change Foot Pedal – Short
- Versius 0 Degree Endoscope
- Versius Camera Head Drape
- Versius Curved Scissors
- Versius Instrument Bedside Unit Drape (Long)
- Versius Instrument Bedside Unit Drape (Standard) - Pack of 5
- Versius Needle Holder
Showing 12 of 33 declared devices.
Catalogue references include 10900/5, 21101, 21201, 21300, 21900, 90400.
European nomenclature codes declared: T030299, Z12020101, Z12020199, L1304, V9099, L181003.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CMR SURGICAL LIMITED (GB) · FDA 3015488559 |
| Devices in EUDAMED | 33 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 33 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 27.3 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. CMR Surgical Limited is registered in the United States but was not found in the Canadian register.