FDA Registration
Active
🇺🇸 United States
SRS MEDICAL
Reg #: 1223851
·
FEI: 3033428382
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- SRS MEDICAL
- Registration Number
- 1223851
- FEI Number
- 3033428382
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 321 Billerica Rd
- City
- Chelmsford
- State
- MA
- ZIP
- 01824
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063447
- PMA Number
- P060010
Owner / Operator
- Firm Name
- SRS MEDICAL
- Operator Number
- 9009409
- Address
- 321 Billerica Road
- City
- Chelmsford
- State
- MA
- Postal Code
- 01824
- Country
- US
- Correspondent
- LEE - BRODY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2008-04-01 |
| Cystometer, Electrical Recording | EXQ | Class 2 | Gastroenterology, Urology | No | 2008-04-01 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2003-03-26 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2008-04-01 |
| Stent, Urethral, Prostatic, Semi-Permanent | NZC | Class 3 | Unknown | No | 2013-05-09 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2022-04-19 |
Proprietary Names
EasyFlo
CT3000
CT3000Pro
CT3000Plus
EasyPro
EasyPro One
GENESIS SERIES
INSIGHT MILLENNIUM
Insight Discovery
The Spanner Temporary Prostatic Stent
CT3000Pro, UroCuff
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device