FDA Registration
Active
🇺🇸 United States
HEALTHTEX DISTRIBUTORS, INC.
Reg #: 3000206696
·
FEI: 3000206696
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
1
Classifications
5
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Registration Details
- Registration Name
- HEALTHTEX DISTRIBUTORS, INC.
- Registration Number
- 3000206696
- FEI Number
- 3000206696
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3555 NW 41 Street
- City
- Miami
- State
- FL
- ZIP
- 33142
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152508
Owner / Operator
- Firm Name
- Healthtex Distributors, Inc.
- Operator Number
- 10027903
- Address
- 3555 NW 41 Street
- City
- Miami
- State
- FL
- Postal Code
- 33142
- Country
- US
- Correspondent
- Yvette Barreto
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-04 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-21 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-11-11 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-07-24 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-28 |
Proprietary Names
Digital Thermometer
Gown
Oximeter Acurio
Face Mask
Oximeter
Thermometer
Establishment Types
Repack or Relabel Medical Device