Data / Medical devices / United States / CellEra, LLC
CellEra, LLC: FDA-registered device maker in Monroe, OH, United States, 8 510(k) clearances
CellEra, LLC is registered with the FDA (registration 3007594734) in Monroe, OH, United States. It lists 11 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 20, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007594734
- Address
- 1045 Reed Road Unit C, Monroe, OH, United States, 45050
- Owner or operator
- CellEra, LLC (10029252)
- Roles
- Complaint file establishment
- First device listed
- April 22, 2009
- Registered through
- 2026
- Brand names listed
- Glucertain Blood Glucose Test Strips, Glucertain Safety Lancets, Total Surgical Collagen Dressings, Vitale Adhesive Foam Dressing, Vitale Collagen Dressing, Vitale Collagen Dressings, Vitale Collagen Powder, Vitale Composite Dressing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | 1 | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Complaint file establishment | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Complaint file establishment | accessdata.fda.gov |
| Silicone Hydrogel For Scar Management | PFP | 1 | Complaint file establishment | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 20, 2025 | K242985 | CollOvine Wound Dressing | KGN | Substantially Equivalent | Ovigenex, LLC | accessdata.fda.gov |
| September 20, 2022 | K213598 | LUOFUCON Collagen Wound Dressing | KGN | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| May 31, 2022 | K210987 | IRRIGO Wound Wash Jet System | FQH | Substantially Equivalent | Inopro, Inc. | accessdata.fda.gov |
| June 1, 2015 | K143335 | Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) | FRO | Substantially Equivalent | Roosin Medical Devices Co., Ltd. | accessdata.fda.gov |
| December 23, 2011 | K112901 | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | Substantially Equivalent | Eps Bio Technology Corp. | accessdata.fda.gov |
| March 13, 2007 | K060832 | RETRO-TECH DRESSING | FRO | Substantially Equivalent | Retro-Tech, LLC | accessdata.fda.gov |
| February 27, 2004 | K040211 | MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| May 15, 2003 | K030921 | COLLAGEN TOPICAL WOUND DRESSING | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2021 | 89453 | Class III | Terminated | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. | accessdata.fda.gov |
| September 1, 2016 | 83281 | Class II | Terminated | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 | Adhesive border was not sticky enough. | accessdata.fda.gov |
Compare with other makers
- All makers of Lavage, Jet
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Dressing, Wound, Occlusive
Updated June 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.