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Keeler Ltd

Active in EUDAMED

United 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

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 695
  • FDA GUDID 97
  • FDA 510(k) 5

A device listed in two registries counts in both.

Device classes
  • EU Class I 666
  • EU Class IIa 15
  • EU Class IIb 14
  • FDA Class II 5
Sites and related companies
Identifiers
  • EUDAMED SRN GB-MF-000009031

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment

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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue700

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Company details

EUDAMED record synced 7 Nov 2026

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)
PRRC contact
Arminder Purewal(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • 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.

Generated automatically from registry data and not verified by a human reviewer.