FDA Registration
Active
🇮🇱 Israel
PressureSafe Scanner
Reg #: 3030646115
·
FEI: 3030646115
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- IRMED LTD.
- Registration Number
- 3030646115
- FEI Number
- 3030646115
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 20 Yahalom St., Z.H.R Industrial Zone
- City
- Rosh Pina Northern
- Country
- IL
Owner / Operator
- Firm Name
- IRMED Inc.
- Operator Number
- 10090410
- Address
- 20 Yahalom St., Z.H.R Industrial Zone
- City
- Rosh Pina
- State
- Northern
- Postal Code
- 1231400
- Country
- IL
US Agent
- Business Name
- QA/RA Consulting Group, Inc.
- Contact Name
- Scott Bednar
- Address
- 3335 Tuscarawas Road
- City
- Beaver
- State
- PA
- ZIP
- 15009
- Country
- US
- [email protected]
- Phone
- 412 4188066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pressure Ulcer Management Tool | QEF | Class 1 | Gastroenterology, Urology | No | 2024-03-25 |
Proprietary Names
PressureSafe Scanner
PressureSafe Disposable Pack
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device