FDA Registration
Active
🇺🇸 United States
TENOVI CO
Reg #: 3017520431
·
FEI: 3017520431
·
Expires 2026
Products
13
Proprietary Names
2
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- TENOVI CO
- Registration Number
- 3017520431
- FEI Number
- 3017520431
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1 Cate Street, STE 100
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251331
Owner / Operator
- Firm Name
- Tenovi Co
- Operator Number
- 10078484
- Address
- 1 Cate Street, STE 100
- City
- Portsmouth
- State
- NH
- Postal Code
- 03801
- Country
- US
- Correspondent
- Nizan Friedman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2026-01-02 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2026-01-02 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2026-01-07 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2022-01-11 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2025-11-20 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-01-24 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-01-24 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2024-01-24 |
| Scale, Stand-On, Patient | FRI | Class 1 | General Hospital | No | 2024-01-24 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2022-10-26 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2024-03-27 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-10-26 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2022-01-11 |
Proprietary Names
Tenovi Bluetooth Pillbox Generation 1
Tenovi Bluetooth Pillbox Generation 2
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198