Acurable Limited
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000010182 FEI 3024891505
Acurable Limited is a medical device manufacturer based in the United Kingdom, with 5 devices listed in FDA 510(k), EUDAMED and FDA GUDID (FDA Class II; EU Class IIa) as of 13 Nov 2026.
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 3
- EUDAMED 1
- FDA GUDID 1
- Device classes
- FDA Class II 4
- EU Class IIa 1
- Top EMDN categories
- Identifiers
- EUDAMED SRN GB-MF-000010182
- FDA FEI 3024891505
- DUNS 221978396
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Acurable Limited makes
Acurable Limited manufactures reusable wearable devices designed to continuously record multiple physiological parameters, including blood oxygen saturation (SpO₂) and heart rate. The AcuPebble series includes models like the AcuPebble Ox (200), AcuPebble OX100, and AcuPebble SA, which are intended for non-invasive monitoring in clinical or ambulatory settings.
These devices are classified as Class II under FDA regulations and are listed under the 510(k) and UDI programs.
Catalogue
Acurable Limited Ref SA100
Regimes: CE MDD Registry: EUDAMED- Regimes: 510(k) Registry: GUDID
AcuPebble Ox (200) Ref K243092
Regimes: 510(k) Registry: 510(k)AcuPebble OX100 Ref K222950
Regimes: 510(k) Registry: 510(k)AcuPebble SA Ref K210480
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- GB-MF-000010182
- FDA FEI number
- 3024891505
- DUNS number
- 221978396
- EU VAT number
- GB270468691
- EUDAMED status
- Active
- EUDAMED registered name
- Acurable Limited
- EUDAMED abbreviated name
- Acurable
- Registered address
- 83, Victoria Street, SW1H 0HW, London, United Kingdom (ex Northern Ireland)
- PRRC contact
- Anas Imtiaz
Frequently asked questions
How many devices does Acurable Limited have in the registry?
The registry currently lists 5 devices for Acurable Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acurable Limited's devices?
Among its 5 most recently registered devices, Acurable Limited has devices listed in EUDAMED (1 device), FDA 510(k) (3 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Acurable Limited's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Acurable Limited's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Acurable Limited in the registry?
The most recently registered devices listed for Acurable Limited include Acurable Limited, AcuPebble Ox100, AcuPebble Ox (200) and AcuPebble SA.