FDA Registration
Active
🇺🇸 United States
ALERA MEDTECH LLC
Reg #: 3042840696
·
FEI: 3042840696
·
Expires 2026
Products
3
Proprietary Names
6
Establishment Types
3
Classifications
3
Registration Details
- Registration Name
- ALERA MEDTECH LLC
- Registration Number
- 3042840696
- FEI Number
- 3042840696
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 159 W Mason Ave
- City
- Buckley
- State
- WA
- ZIP
- 98321
- Country
- US
Owner / Operator
- Firm Name
- Alera Medtech LLC
- Operator Number
- 10093693
- Address
- 77 Rowe Street, Suite 2C
- City
- Auburndale
- State
- MA
- Postal Code
- 02466
- Country
- US
- Correspondent
- Robert Rudelius
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-01-05 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2026-04-18 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2026-01-05 |
Proprietary Names
SureSet Loop Securement Device
SureSet Foley Catheter Securement Device
SureSet Loop Catheter Securement Device - Adult
SureSet Dialysis Catheter Securement Device
SureSet Loop Catheter Securement Device - Pediatric
SureSet Peripheral IV Catheter Securement Device
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device