FDA Registration
Active
🇺🇸 United States
HELMER Inc.
Reg #: 3004973569
·
FEI: 3004973569
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- HELMER Inc.
- Registration Number
- 3004973569
- FEI Number
- 3004973569
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14400 Bergen Blvd
- City
- NOBLESVILLE
- State
- IN
- ZIP
- 46060
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK170141
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 |
|---|---|---|---|---|---|
| Refrigerator, Freezer, Blood Storage | KSE | Class 2 | Hematology | No | 2000-12-04 |
| Chamber, Environmental For The Storage Of Platelet Concentrate | KSH | Class 2 | Hematology | No | 2004-09-08 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2004-09-08 |
| Device, Blood Mixing And Blood Weighing | KSQ | Class 1 | Hematology | No | 2004-09-08 |
| Freezer | JRM | Class 1 | Clinical Chemistry | No | 2017-08-08 |
| Centrifuge, Cell-Washing, Automated For Immuno-Hematology | KSN | Class 2 | Hematology | No | 2018-03-19 |
Proprietary Names
Helmer Plasma Storage Freezer
Helmer Blood Storage Refrigerator
HELMER PLATELET INCUBATOR
PLASMA THAWING SYSTEM
Laboratory and Pharmacy Refrigerator and Freezer
HELMER PLATELET AGITATOR
Ultra Low Freezer
UltraCW II
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)