FDA Registration
Active
🇺🇸 United States
IMPILO, Inc.
Reg #: 3022147580
·
FEI: 3022147580
·
Expires 2026
Products
10
Proprietary Names
15
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- IMPILO, Inc.
- Registration Number
- 3022147580
- FEI Number
- 3022147580
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2275 Bridge street, Building 208, unit 110, 300
- City
- Philadelphia
- State
- PA
- ZIP
- 19137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201467
Owner / Operator
- Firm Name
- Impilo Health
- Operator Number
- 10086162
- Address
- 2275 Bridge Street
- City
- Philadelphia
- State
- PA
- Postal Code
- 19137
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-06-30 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2025-07-03 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2025-06-30 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2025-07-03 |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2025-07-03 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-07-03 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2025-07-03 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-07-03 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2025-06-30 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2025-07-03 |
Proprietary Names
Bioland Blood Pressure Monitor
Instant Hot Pack
Bioland Glucose Monitoring System
Absorbent Sheet 50 mL 3x4
Impilo Collection Kit - 1140
Guangdong Transtek Medical Electronics Co
MICROTAINER BRAND TUBE WITH EDTA
TRANSTEK BLOOD PRESSURE MONITOR
McKesson Gauze Sponge 2X2 [1ct]
Fingertip Bandage
iGlucose Glucose Monitoring System
Transtek TeleRPM BPM Gen-2
TASSO Blood Lancing Device
Mio Blood Glucose Monitoring System
iHealth Track
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)