FDA Registration
Active
🇺🇸 United States
i-Health, Inc.
Reg #: 1221895
·
FEI: 1221895
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- i-Health, Inc.
- Registration Number
- 1221895
- FEI Number
- 1221895
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- a division of dsm-firmenich, 25 Bacon Road, Suite 102
- City
- Enfield
- State
- CT
- ZIP
- 06082
- Country
- US
Regulatory Submissions
- 510(k) Number
- K260007
Owner / Operator
- Firm Name
- i-Health, Inc., a division of DSM-FIRMENICH
- Operator Number
- 10026311
- Address
- 2 Corporate Drive, Suite 445
- City
- Shelton
- State
- CT
- Postal Code
- 06484
- Country
- US
- Correspondent
- Julie M Bagley
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Personal | NUC | Class 2 | Obstetrics/Gynecology | No | 2026-06-19 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2022-06-28 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2016-02-10 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2016-02-10 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2025-12-02 |
Proprietary Names
AZO Vaginal Moisturizer Suppositories
AZO Vaginal pH Test
AZO Test Strips(R)
Establishment Types
Complaint File Establishment per 21 CFR 820.198