FDA Registration
Active
🇺🇸 United States
CellEra, LLC
Reg #: 3007594734
·
FEI: 3007594734
·
Expires 2026
Products
10
Proprietary Names
24
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- CellEra, LLC
- Registration Number
- 3007594734
- FEI Number
- 3007594734
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1045 Reed Road, Unit C
- City
- Monroe
- State
- OH
- ZIP
- 45050
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040211
Owner / Operator
- Firm Name
- CellEra, LLC
- Operator Number
- 10029252
- Address
- 1045 Reed Road, Unit C
- City
- Monroe
- State
- OH
- Postal Code
- 45050
- Country
- US
- Correspondent
- Ken Heyl
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2021-10-28 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2009-04-23 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2009-04-22 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2016-12-04 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2012-01-06 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2023-08-31 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2017-06-03 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2017-06-03 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2009-04-23 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2014-04-23 |
Proprietary Names
Vitale Collagen Dressings
Vitale Silicone Super Absorbent Dressings
Vitale Hydroconductive Dressings
Vitale Cover Dressing
Vitale STRONG Calcium Alginate Dressings
Vitale Hydrogel Dressing
Vitale STRONG Silver Calcium Alginate Dressing
Glucertain Safety Lancets
Vitale Wound Wash Jet System
Vitale RTD Wound Dressing
Glucertain Blood Glucose Test Strips
Vitale Adhesive Foam Dressing
Vitale Composite Dressing
Vitale Non-Adhesive Foam Dressing
Vitale Silicone Foam Dressing
Vitale Foam Heel Dressing
Vitale Sacral Silicone Foam Dressing
Vitale Hydrocolloid Dressing
Vitale Petrolatum Dressings
Vitale Xeroform Dressings
Vitale Non-Adherent Oil Emulsion Dressings
Vitale Composite Post-Op Dressing
Vitale Skin Protectant Wipes
Vitale Collagen Powder
Establishment Types
Complaint File Establishment per 21 CFR 820.198