Keeler Ltd
GB-MF-000009031 · United Kingdom · Windsor
Keeler Ltd is registered in the European database on medical devices as a manufacturer, with 702 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 688 |
|---|---|
| Class IIb | 14 |
Among these devices, 2 are declared sterile, 431 active, 23 with a measuring function.
Authorised representative in the Union: Keeler Europe Distribution, S.L..
Devices declared under this manufacturer
- 2.5MM EXTENDED RETINAL PROBE
- 2.8V POCKET HANDLE
- 3.0 x 34CM LIGHTWEIGHT GALILEAN LOUPE - 902404
- 3.6V MAGNETIC STREAK RET/PROFESSIONAL OPHTH & HANDLE
- 532nm LIO
- API CORDED - 902396
- K-LED & DOUBLE CHARGER & 2 BATTERIES, CLIP-ON
- PSL CLASSIC - KIT2
- RIESTER API II LED WIRELESS
- SLIMLINE 3.6V SPOT RET & SPECIALIST OPHTH
- SPECTRA+ TEACHING MIRROR
- SUPERVU 2.5 x 34CM GALILEAN LOUPE
Showing 12 of 702 declared devices.
Catalogue references include 1204-P-3070, 1205-P-2005, 1205-P-2130, 1427-P-1065, 2004-P-1009, 2112-P-1024.
European nomenclature codes declared: Q0299, Z12120180, Z12120114, Z12120108, Z12120199, Z12120122.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | KEELER LTD. (GB) · FDA 1000391004 |
| Devices in EUDAMED | 702 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 702 |
|---|---|
| Found in the U.S. device database | 107 |
| Share | 15.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | KEELER LIMITED |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| Class 3 devices | 2 |
| First licensed | 2007-10-10 |
Licence types: System (4), Single Device (3).
Licensed under: PULSAIR INTELLIPUFF TONOMETER, CRYOMATIC CRYOSURGICAL SYSTEM, KEELER APPLANATION TONOMETER (KAT), PULSAIR DESKTOP TONOMETER, KEELER CRYOMATIC MKII CRYOSURGICAL SYSTEM, KEELER DIGITAL APPLANATION TONOMETER (DKAT).
North American profile: Both markets. Keeler Ltd is registered in both the United States and Canada.