FDA Registration
Active
🇺🇸 United States
ALLISON MEDICAL, INC.
Reg #: 1722458
·
FEI: 1000138447
·
Expires 2026
Products
4
Proprietary Names
18
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ALLISON MEDICAL, INC.
- Registration Number
- 1722458
- FEI Number
- 1000138447
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8091 Shaffer Pkwy
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113186
Owner / Operator
- Firm Name
- ALLISON MEDICAL, INC.
- Operator Number
- 9009434
- Address
- 8091 Shaffer Parkway, --
- City
- Littleton
- State
- CO
- Postal Code
- 80127
- Country
- US
- Correspondent
- Isaiah M Ray
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2013-05-02 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2014-11-04 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2012-04-02 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2012-04-02 |
Proprietary Names
SureComfort
EaseInject
CAREPOINT
Sure Comfort Pen Needle
SureComfort Freedom
Healthwise Lancets
Up&Up Lancets
Up&Up Lancing Pens
SureComfort Lancing Pens
SureComfort Lancets
CarePoint
FreeStyle Precision
Premier Value
Select Brand
InControl
Healthwise Alcohol Prep Pads
SureComfort Alcohol Prep Pads
Select Brand Alcohol Prep Pads
Establishment Types
Complaint File Establishment per 21 CFR 820.198