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CODONICS INC.

United States·US-MF-000008190

Last updated May 24, 2026

What CODONICS INC. makes

Codonics Inc. manufactures diagnostic-imaging multiformat cameras, medical printer film, and DICOM image data disc-recording units. The company also produces parenteral-nutrition management software, mobile anaesthesia units, and point-of-care medication labeling systems.

The company is based in the United States and maintains a portfolio consisting of Class I and Class II medical devices. These products are listed in the FDA 510(k) and UDI databases, as well as the EUDAMED registry.

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

Frequently asked questions

Where is Codonics Inc. based and what do they manufacture?

Codonics Inc. is based in the United States. The company manufactures a range of medical products including diagnostic-imaging multiformat cameras, medical printer film, and DICOM image data disc-recording units. Additionally, they produce parenteral-nutrition management software, mobile anaesthesia units, and point-of-care medication labeling systems, such as the Safe Label System.

How are the medical devices from Codonics Inc. classified?

The medical devices manufactured by Codonics Inc. are classified as either Class I or Class II devices. This classification system is used by regulatory bodies to categorize devices based on the level of risk they pose to patients and users, with Class I generally representing lower risk and Class II representing moderate risk.

Which regulatory registries list the devices produced by Codonics Inc.?

Devices manufactured by Codonics Inc. are listed in several major regulatory databases, including the FDA 510(k) database, the FDA UDI (Unique Device Identification) database, and the EUDAMED registry. These listings provide transparency and regulatory oversight for the company's portfolio of imaging, software, and labeling products.

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

Information

Country: United States
Address: 17991 , Englewood Drive, Middleburg Heights, United States
Website: www.codonics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 12165701571
PRRC Contact: Vince Yee
EUDAMED SRN: US-MF-000008190
FDA FEI Number: —
DUNS Number: 101533727

Catalogue (86)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Codonics DirectVista Thermal Film, 810-DVB	810-DVB	FDA UDI	Class I	Active
Codonics Safe Label System® Administration Tool	2.2.0	FDA UDI	Class II	Active
Codonics Safe Label System®(SLS) 500i Point of Care Station	500i PCS -140C	FDA UDI	Class II	Active
Codonics Horizon® Operating Software	3.0.2	FDA UDI	Class II	Active
Codonics Horizon® Multi-media Imager	52C	FDA UDI	Class II	Active
Codonics SLS500i Operating Software	2.1.2	FDA UDI	Class II	Active
Codonics DirectVista Thermal Film, 1417-DVB	1417-DVB	FDA UDI	Class I	Active
Codonics Horizon® Multi-media Imager	54C	FDA UDI	Class II	Active
Codonics Virtua® XR Controller - 74C	Virtua XR - 74C	FDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1114-DVB5	1114-DVB5	FDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1417-DVB5	1417-DVB5	FDA UDI	Class I	Active
Codonics Horizon® Operating Software	4.2.0	FDA UDI	Class II	Active
Codonics Virtua® Controller - 71C	Virtua -71C	FDA UDI	Class I	Active
Codonics Horizon® Operating Software	4.1.2	FDA UDI	Class II	Active
Codonics Thermal GS Paper/White Film, 810	810-DVP	FDA UDI	Class I	Active
Codonics SLS500i Operating Software	2.1.1	FDA UDI	Class II	Active
Codonics SLS500i Operating Software	2.1.3	FDA UDI	Class II	Active
Codonics DirectVista Thermal Film, 1417-DVB5	1417-DVB5	FDA UDI	Class I	Active
Codonics SLS500i Operating Software	2.2.0	FDA UDI	Class II	Active
Codonics Horizon® Operating Software	2.1.3	FDA UDI	Class II	Active
Codonics Safe Label System®(SLS) 550i Point of Care Station - 144C	550i PCS	FDA UDI	Class II	Active
Codonics DirectVista Thermal Film, 810-DVC	810-DVC	FDA UDI	Class I	Active
Codonics Safe Label System® Administration Tool	2.1.0	FDA UDI	Class II	Active
Codonics Safe Label System®(SLS) 550i Point of Care Station	550i PCS - 143C	FDA UDI	Class II	Active
Codonics Horizon® Multi-media Imager	51C	FDA UDI	Class II	Active
Codonics Horizon® Ci Multi-media Imager	Ci	FDA UDI	Class II	Active
Codonics DirectVista Thermal Film, 810-DVB5	810-DVB5	FDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVB5	810-DVB5	FDA UDI	Class I	Active
Codonics Virtua® XR Controller - 72C	Virtua XR - 72C	FDA UDI	Class I	Active
Codonics Safe Label System®(SLS) 500i Point of Care Station	500i PCS -141C	FDA UDI	Class II	Active
Codonics Virtua® XR Controller - 76C	Virtua XR - 76C	FDA UDI	Class I	Active
Codonics Virtua® C Controller - 91C	Virtua C -91C	FDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVB	810-DVB	FDA UDI	Class I	Active
Codonics Horizon® Multi-media Imager	50C	FDA UDI	Class II	Active
Codonics Virtua® C Controller - 90C	Virtua C -90C	FDA UDI	Class I	Active
Codonics Safe Label System®(SLS) 500i Point of Care Station	500i PCS -142C	FDA UDI	Class II	Active
Codonics Horizon® Multi-media Imager	150C	FDA UDI	Class II	Active
Codonics DirectVista Thermal Film, 1114-DVB5	1114-DVB5	FDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVC	810-DVC	FDA UDI	Class I	Active
Codonics Virtua® Controller - 75C	Virtua -75C	FDA UDI	Class I	Active
Codonics Horizon® Multi-media Imager	55C	FDA UDI	Class II	Active
Codonics Horizon® Multi-media Imager	53C	FDA UDI	Class II	Active
Codonics Virtua® C Controller - 92C	Virtua C -92C	FDA UDI	Class I	Active
Codonics Virtua® Controller - 73C	Virtua - 73C	FDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVB	810-DVB	EUDAMED	Class I	Active
Codonics DirectVista Thermal Film, 810-DVB5	810-DVB5	EUDAMED	Class I	Active
Codonics Horizon® SF Multi-media Imager	HZSF	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1417-DVC	1417-DVC	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1436-DVB5	1436-DVB5	EUDAMEDFDA UDI	Class I	Active
Virtua XR	VirtuaXR	EUDAMEDFDA UDI	Class I	Active

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