FDA Registration
Active
🇬🇧 United Kingdom
KEELER LTD.
Reg #: 1000391004
·
FEI: 1000391004
·
Expires 2026
Products
21
Proprietary Names
0
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- KEELER LTD.
- Registration Number
- 1000391004
- FEI Number
- 1000391004
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CLEWER HILL RD.
- City
- WINDSOR, BERKSHIRE Windsor and Maidenhead
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K133234
Owner / Operator
- Firm Name
- KEELER LTD.
- Operator Number
- 9011500
- Address
- CLEWER HILL RD.
- City
- WINDSOR, BERKSHIRE
- State
- GB-NOTA
- Postal Code
- SL4 4AA
- Country
- GB
- Correspondent
- Claudia B Hill
US Agent
- Business Name
- Keeler USA
- Contact Name
- Claudia Hill
- Address
- 3222 Phoenixville Pike
- City
- Malvern
- State
- PA
- ZIP
- 19355
- Country
- US
- [email protected]
- Phone
- 610 8890200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2018-12-11 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2015-12-01 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2011-02-02 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2022-03-08 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2020-05-01 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2008-03-26 |
| Grid, Amsler | HOQ | Class 1 | Ophthalmic | No | 2008-03-26 |
| Transilluminator, Ac-Powered | HJM | Class 2 | Ophthalmic | No | 2008-03-26 |
| Unit, Cryophthalmic, Ac-Powered | HRN | Class 2 | Ophthalmic | No | 2008-03-26 |
| Tester, Color Vision | HIT | Class 1 | Ophthalmic | No | 2008-03-26 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 2008-03-26 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2025-03-26 |
| Ophthalmoscope, Battery-Powered | HLJ | Class 2 | Ophthalmic | No | 2007-12-11 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2021-07-01 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2005-11-09 |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | Class 1 | Ophthalmic | No | 2008-03-26 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-09-19 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-09-19 |
| Retinoscope, Ac-Powered | HKL | Class 2 | Ophthalmic | No | 2008-03-26 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2008-03-26 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2008-06-27 |
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)