FDA Registration
Active
🇺🇸 United States
ARCHE HEALTHCARE
Reg #: 3003771601
·
FEI: 3003771601
·
Expires 2026
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ARCHE HEALTHCARE
- Registration Number
- 3003771601
- FEI Number
- 3003771601
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 23 Split Rock Road
- City
- Pound Ridge
- State
- NY
- ZIP
- 10576
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080816
Owner / Operator
- Firm Name
- Arche Healthcare
- Operator Number
- 10025074
- Address
- 23 Split Rock Road
- City
- Pound Ridge
- State
- NY
- Postal Code
- 10576
- Country
- US
- Correspondent
- Scott R Kantro
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2012-07-16 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2024-11-07 |
| System, Pressure Measurement, Intermittent | JFC | Class 1 | Physical Medicine | No | 2008-03-12 |
| Foot Examination Tool For Inflammatory Changes | OIZ | Class 1 | Physical Medicine | No | 2010-02-04 |
| Esthesiometer | GXB | Class 1 | Neurology | No | 2024-11-07 |
Proprietary Names
VibraTip
DermaStat
PressureStat
TempStat
Bailey Monofilament
Establishment Types
Repack or Relabel Medical Device