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HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION: Public Query
Establishment Details
Establishment Name and Location
Current Status: Registered
Last Annual Registration Year: 2026
FDA Establishment Identifier (FEI): 3033413967
Establishment Name: Akesoe Biologics LLC
Address: 1341 Sundial Point
City: Winter Springs
State: Florida
Zip: 32708
Country: UNITED STATES
Phone: 407-773-1994
Establishment Functions
| Types of HCT/Ps | Recover | Screen | Donor Testing | Package | Process | Store | Label | Distribute |
|---|---|---|---|---|---|---|---|---|
| Amniotic Membrane | ||||||||
| Blood Vessel | ||||||||
| Bone | ||||||||
| Cardiac Tissue, non-valved | ||||||||
| Cartilage | ||||||||
| Cornea | ||||||||
| Dura Mater | ||||||||
| Embryo | ||||||||
| Fascia | ||||||||
| Heart Valve |
Establishment HCT/P Listing
| Types of HCT/Ps | HCT/Ps Described in 21 CFR 1271.10 | Proprietary Names |
|---|---|---|
| Amniotic Membrane | X | Akesoe SL, Akesoe DL, Akesoe TL, Natevus DM, CHEQD DL, Precision DM |
| Blood Vessel | ||
| Bone |
HCT/P Listing: Donor Information
| Types of HCT/Ps | SIP | Directed | Anonymous | Autologous | Family Related |
|---|---|---|---|---|---|
| Embryo |
Akesoe Biologics, LLC is registered with the U.S. Food and Drug Administration as a human cell and tissue establishment and lists its HCT/Ps in accordance with 21 CFR Part 1271. FDA registration and product listing do not constitute FDA approval, clearance, or endorsement of the establishment or its products. Akesoe DL is intended for homologous use as a barrier or covering.
