CellEra, LLC (other, Monroe, OH): 1 new FDA device listing, incl. wound dressing with animal-derived material(s)
CellEra, LLC (Monroe, Ohio): 1 new FDA device listing, incl. wound dressing with animal-derived material(s). Its amount of 1 is above the median of 1 (50th percentile). Dated 52 days ago, it serves as a historical benchmark. Score 35/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 13 published fields of this record are shown below. Locked: 41 related OH DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | CellEra, LLC |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Monroe, OH, US |
| New listings | 1 |
| Devices | Wound Dressing With Animal-Derived Material(S) |
| Product codes | KGN |
| Device classes | Unclassified |
| Brand names | Vitale Collagen Dressing; Total Surgical Collagen Dressings |
| First new listing | 2026-09-14 |
| Latest new listing | 2026-09-14 |
| FDA registration number | 3007594734 |
| Registration expires | 2026-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (42 OH records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-14
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (OH first): Sterigenics US, LLC (contract sterilizer, Lewis Center, OH) · Aps Materials, Inc. (contract manufacturer, Dayton, OH) · Health Care Logistics, Inc. (repackager or relabeler, Urbanc · Hammill Mfg. Co. (contract manufacturer, Maumee, OH) · Guardian Medical USA, Inc (contract manufacturer, Swanton, O · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: CellEra, LLC and 42 Ohio peers
- Ohio DeviceEstablishmentPulse records like this one: 42
- CellEra, LLC's amount: 50th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Ohio peer: $8,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Score
- U.S. establishment.
What is the DeviceEstablishmentPulse record for CellEra, LLC in Monroe, Ohio?
CellEra, LLC (Monroe, OH), a other, added 1 FDA device listing on 2026-09-14.
How does CellEra, LLC compare to other Ohio DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 52 days old; check the official source for later updates before acting. Its Score of 35/100 is modest; treat it as background rather than a priority.
CellEra, LLC vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| CellEra, LLC | Monroe, OH | 1 | 50th | 2026-09-14 |
| Conmed Corporation | Utica, NY | 3 | 77th | 2026-09-14 |
| Euroimmun Us Inc. | Mountain Lakes, NJ | 3 | 77th | 2026-09-10 |
| Rohrer Aesthetics, Inc. | Homewood, AL | 3 | 77th | 2026-09-09 |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.