Keeler Ltd
Active in EUDAMEDUnited Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000009031
Keeler Ltd is a medical device manufacturer based in the United Kingdom, with 700 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I, IIa and IIb; FDA Class II) as of 15 Nov 2026.
- Devices
- 700
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 695
- FDA GUDID 97
- FDA 510(k) 5
- Device classes
- EU Class I 666
- EU Class IIa 15
- EU Class IIb 14
- FDA Class II 5
- Top EMDN categories
- Sites and related companies
- Keeler Europe Distribution, S.L. authorised representative
- Identifiers
- EUDAMED SRN GB-MF-000009031
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- Keeler Europe Distribution, S.L.ES
What Keeler Ltd makes
Keeler Ltd manufactures ophthalmic examination tools, including handheld and portable retinoscopes (e.g., 3.6V professional streak LED bundles and student sets), slit lamps (e.g., USA refraction stand kits), and diagnostic loupes (e.g., +1D near-distance caps and Galilean loupe sets). The company also produces accessories like LED stand chargers, soft cases for equipment, and magnetic streak retinoscopes. Additional products include tonometers (e.g., TonoCare) and LED-based diagnostic instruments (e.g., SLH 5XC LED dioptric refraction).
The company’s devices are classified under EU regulations as Class I, Class II, Class IIa, and Class IIb, with corresponding FDA submissions via the 510(k) pathway. Products are registered in the EU’s eudamed database and the FDA’s 510(k) registry. Keeler Ltd is based in the United Kingdom.
Catalogue
Search and filter all 700 devicesShowing 1-50 of 700
Company details
- EUDAMED SRN
- GB-MF-000009031
- EU VAT number
- GB 349 0761 40
- EUDAMED status
- Active
- EUDAMED registered name
- Keeler Ltd
- Registered address
- Clewer Hill Road, SL4 4AA, Windsor, United Kingdom (ex Northern Ireland)
- Website
- www.keelerglobal.com
- PRRC contact
- Arminder Purewal
FDA establishments
- Keeler Limited US
Frequently asked questions
How many devices does Keeler Ltd have in the registry?
The registry currently lists 700 devices for Keeler Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Keeler Ltd's devices?
Among its 50 most recently registered devices, Keeler Ltd has devices listed in EUDAMED (50 devices).
What risk classes do Keeler Ltd's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Keeler Ltd's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Keeler Ltd in the registry?
The most recently registered devices listed for Keeler Ltd include RIESTER STD LED CHARGER & BATTERY, RETINOSCOPE BROW REST (LONG), LOUPE FLIP LEVER (PACK OF 7) and 5 PROTECTIVE SHIELDS - REGULAR.
Which FDA establishments are linked to Keeler Ltd?
1 FDA establishment is linked to Keeler Ltd in the registry; they are listed on the company page.