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CellEra, LLC

Last updated September 17, 2026

What CellEra, LLC makes

CellEra, LLC produces a range of wound care dressings, including hydrophilic-gel and non-gel exudate-absorbent products, both antimicrobial and non-antimicrobial variants. Their portfolio also includes nonadherent wound dressings, petrolatum woven gauze pads, animal-derived wound matrix dressings, and non-antimicrobial wound hydrogels. The company’s offerings are designed for managing exudative and non-exudative wounds, with some formulations incorporating antimicrobial properties.

The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with all products listed in the FDA’s Unique Device Identifier (UDI) database. CellEra, LLC operates from the United States, adhering to U.S. regulatory requirements for medical device compliance.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does CellEra, LLC manufacture?

CellEra, LLC specializes in wound care dressings, including exudate-absorbent products like hydrophilic-gel and non-gel variants, some of which have antimicrobial properties. Their portfolio also covers nonadherent wound dressings, petrolatum woven gauze pads, animal-derived wound matrix dressings, and non-antimicrobial wound hydrogels. These products are designed to manage wounds with varying levels of exudate and infection risk.

Where is CellEra, LLC based, and does that affect its regulatory compliance?

CellEra, LLC is based in the United States, which means its devices must comply with U.S. regulatory standards, including those set by the FDA. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they are subject to U.S. medical device regulations, which vary depending on classification (e.g., Class I, Class II, or Unclassified).

Which regulatory registries or databases list CellEra, LLC’s devices?

CellEra, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorized in the U.S. The UDI system helps healthcare providers and regulators identify and verify specific products, including those manufactured by CellEra.

How are CellEra, LLC’s devices classified under FDA regulations?

CellEra, LLC’s devices fall into different FDA classification categories: Class I (generally low-risk), Class II (moderate risk requiring special controls), and Unclassified (U) devices. Classification determines the regulatory pathway and oversight required for each product, ensuring appropriate safety and performance standards are met before authorization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 1045 Reed Road, Monroe, OH, 45050
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3007594734
DUNS Number: —

Catalogue (157)

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Device	Model / Reference	Registries	Class	Status
Vitale	21044	FDA UDI	Class I	Unknown
Glucertain	30190	FDA UDI	Class II	Active
Vitale	20844	FDA UDI	Class I	Active
Vitale	23845	FDA UDI	Class I	Active
Vitale	24006	FDA UDI	Class I	Active
Vitale	20133	FDA UDI	Class I	Active
Vitale	20190	FDA UDI	Class I	Unknown
Vitale STRONG	20576	FDA UDI	U	Active
Vitale STRONG	20655	FDA UDI	Class I	Active
Vitale	20166	FDA UDI	Class I	Active
Vitale	22000	FDA UDI	U	Active
Vitale	24707	FDA UDI	Class I	Active
Vitale	25266	FDA UDI	Class I	Active
Vitale STRONG	20656	FDA UDI	Class I	Active
Vitale	20366	FDA UDI	Class I	Active
Vitale	20800	FDA UDI	Class I	Active
Vitale	23844	FDA UDI	Class I	Active
Vitale	20245	FDA UDI	Class I	Active
Vitale STRONG	20574	FDA UDI	U	Active
Vitale	24544	FDA UDI	Class I	Active
Vitale	21244	FDA UDI	Class I	Active
Vitale	57202	FDA UDI	Class I	Active
Vitale	20545	FDA UDI	U	Active
Vitale	20400	FDA UDI	Class I	Active
Vitale	24506	FDA UDI	Class I	Active
Vitale STRONG	20672	FDA UDI	Class I	Active
Vitale	24002	FDA UDI	Class I	Active
Vitale	24548	FDA UDI	Class I	Active
Vitale	20622	FDA UDI	Class I	Active
Vitale	20644	FDA UDI	Class I	Active
Vitale	20923	FDA UDI	Class I	Active
Vitale STRONG	20552	FDA UDI	U	Active
Vitale	20280	FDA UDI	Class I	Unknown
Vitale	21222	FDA UDI	Class I	Active
Vitale	20844	FDA UDI	Class I	Active
Vitale	20622	FDA UDI	Class I	Active
Vitale STRONG	20554	FDA UDI	U	Active
Vitale	23822	FDA UDI	Class I	Active
Vitale	22044	FDA UDI	U	Active
Vitale	20444	FDA UDI	Class I	Active
Vitale	22088	FDA UDI	U	Active
Vitale	20267	FDA UDI	Class I	Unknown
Vitale	20522	FDA UDI	U	Active
Vitale	24506	FDA UDI	Class I	Active
Vitale	24106	FDA UDI	Class I	Active
Vitale STRONG	20575	FDA UDI	U	Active
Vitale	20044	FDA UDI	U	Active
Vitale	20144	FDA UDI	Class I	Unknown
Vitale	24004	FDA UDI	Class I	Active
Vitale STRONG	20652	FDA UDI	Class I	Active

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Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

CellEra, LLC has six FDA recall records, all initiated between September 1, 2016, and December 15, 2021, with each record marked as terminated. The reasons cited include issues with adhesive borders lacking sufficient stickiness and the inclusion of incorrect Instructions for Use (IFU) that exceeded the language cleared under the 510(k) submission, with the firm replacing those documents with the correct versions.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Dec 15, 2021	Z-0802-2022	—	terminated	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.
Dec 15, 2021	Z-0801-2022	—	terminated	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.
Dec 15, 2021	Z-0804-2022	—	terminated	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.
Dec 15, 2021	Z-0805-2022	—	terminated	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.
Dec 15, 2021	Z-0803-2022	—	terminated	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.
Sep 1, 2016	Z-2085-2019	—	terminated	Adhesive border was not sticky enough.