FDA Registration
Active
🇺🇸 United States
ALDEN MEDICAL LLC
Reg #: 1221361
·
FEI: 1221361
·
Expires 2026
Products
3
Proprietary Names
7
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- ALDEN MEDICAL LLC
- Registration Number
- 1221361
- FEI Number
- 1221361
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 360 Cold Spring Ave
- City
- W Springfield
- State
- MA
- ZIP
- 01089
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113015
Owner / Operator
- Firm Name
- ALDEN MEDICAL LLC
- Operator Number
- 9064620
- Address
- 360 COLD SPRING AVE., --
- City
- West Springfield
- State
- MA
- Postal Code
- 01089
- Country
- US
- Correspondent
- DAMON - D'AMICO
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2007-12-05 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2020-12-23 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2007-12-05 |
Proprietary Names
Compliance
Micro-X
Peracidin
PerAldecide
Aldahol 1.8
Compat
Metricide OPA Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device