FDA Registration
Active
🇺🇸 United States
Ultra Low Freezer
Reg #: 3004973569
·
FEI: 3004973569
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HELMER Inc.
- Registration Number
- 3004973569
- FEI Number
- 3004973569
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14400 Bergen Blvd
- City
- NOBLESVILLE
- State
- IN
- ZIP
- 46060
- Country
- US
Owner / Operator
- Firm Name
- HELMER INC.
- Operator Number
- 2182537
- Address
- 14400 BERGEN BLVD., --
- City
- Noblesville
- State
- IN
- Postal Code
- 46060
- Country
- US
- Correspondent
- RENEE - SCHULTZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Freezer | JRM | Class 1 | Clinical Chemistry | No | 2017-08-08 |
Proprietary Names
Ultra Low Freezer
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device