Cmr Surgical Limited
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000010885 FEI 3015488559
Part of Cmr Surgical Limited
- Devices
- 56
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment, FDA recalls
- Authorised rep.
- Advena LimitedMT
Catalogue
Search and filter all 56 devicesShowing 1-50 of 56
Company details
- EUDAMED SRN
- GB-MF-000010885
- FDA FEI number
- 3015488559
- DUNS number
- 219860797
- EU VAT number
- GB 186 4383 74
- EUDAMED status
- Active
- EUDAMED registered name
- CMR Surgical Limited
- EUDAMED abbreviated name
- CMR
- Registered address
- 1, 1 Evolution Business Park, CB24 9NG, Cambridge, United Kingdom (ex Northern Ireland)
- Website
- cmrsurgical.com/
- linkedin.com/company/cmrsurgical
- [email protected]
- Phone
- +44 (0) 1223 755 300
- PRRC contact
- Kimberley Baillie
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 1
2026
- 9 Jun 2026 Z-2717-2026 Class II Ongoing Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
FDA establishments
- Cmr Surgical Limited Cambridge Cambridgeshire · GB FEI 3015488559
From the company website
Versius is a modular & portable surgical robot designed to make it easier for hospitals and surgeons to give patients access to minimal access surgery.
Frequently asked questions
How many devices does CMR SURGICAL LIMITED have in the registry?
The registry currently lists 56 devices for CMR SURGICAL LIMITED. Devices recorded under merged duplicate company entries are counted once.
Which registries list CMR SURGICAL LIMITED's devices?
Among its 50 most recently registered devices, CMR SURGICAL LIMITED has devices listed in EUDAMED (34 devices), FDA 510(k) (2 devices) and FDA GUDID (21 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CMR SURGICAL LIMITED's devices fall under?
Among its 50 most recently registered devices, the classes recorded for CMR SURGICAL LIMITED's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for CMR SURGICAL LIMITED?
FDA recall records list 1 recall initiated by CMR SURGICAL LIMITED, the most recent initiated on 2026-06-09. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from CMR SURGICAL LIMITED in the registry?
The most recently registered devices listed for CMR SURGICAL LIMITED include Versius Visualisation Bedside Unit, Versius Bipolar Maryland Grasper, Versius Monopolar Hook and Versius Instrument Bedside Unit.
Which FDA establishments are linked to CMR SURGICAL LIMITED?
1 FDA establishment is linked to CMR SURGICAL LIMITED in the registry; they are listed on the company page.