FDA Registration
Active
🇺🇸 United States
BioStamp nPoint®
Reg #: 3017481564
·
FEI: 3017481564
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Medidata Solutions
- Registration Number
- 3017481564
- FEI Number
- 3017481564
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 110 High St
- City
- Boston
- State
- MA
- ZIP
- 02110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173510
Owner / Operator
- Firm Name
- Medidata, a Dassault Systemes company
- Operator Number
- 10026099
- Address
- 350 Hudson Street, Floor 9
- City
- New York
- State
- NY
- Postal Code
- 10014
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2020-10-17 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2020-10-17 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2020-10-17 |
| Device, Sleep Assessment | LEL | Class 2 | Neurology | No | 2020-10-17 |
Proprietary Names
BioStamp nPoint®
Establishment Types
Complaint File Establishment per 21 CFR 820.198