FDA Registration
Active
🇬🇧 United Kingdom
DFI Co., Ltd.
Reg #: 3006798115
·
FEI: 3006798115
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- Home Health (UK) Ltd.
- Registration Number
- 3006798115
- FEI Number
- 3006798115
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit A, Greatham Road Industrial Estate,, Greatham Road
- City
- Bushey Hertfordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K181024
Owner / Operator
- Firm Name
- Home Health (UK) Ltd.
- Operator Number
- 10023140
- Address
- Unit A, Greatham Road Industrial Estate, Greatham Road,
- City
- Bushey
- State
- Hertfordshire
- Postal Code
- WD23 2NZ
- Country
- GB
- Correspondent
- Mark R Hanson
US Agent
- Business Name
- Home Health (US)
- Contact Name
- Mark Hanson
- Address
- 4414 Useppa Drive
- City
- Bradenton
- State
- FL
- ZIP
- 34203
- Country
- US
- [email protected]
- Phone
- 941 2422952
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2021-11-19 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2021-11-19 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2021-11-19 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2021-11-19 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2021-11-19 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2021-11-19 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2021-11-19 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2021-11-19 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2021-11-19 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2021-11-19 |
Proprietary Names
DFI Co., Ltd.
Establishment Types
Repack or Relabel Medical Device
Foreign Private Label Distributor