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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 2 of 2

Device	Model / Reference	Registries	Class	Status
Codonics DirectVista Thermal Film, 1417-DVB5	1417-DVB5	EUDAMED	Class I	Active
Codonics Horizon Ci Medical Multimedia Dry Imager; Codonics Horizon Gs Medical Multimedia Grey Scale Dry Imager	K021054	FDA 510(k)	Class II	Active
Codonics Medical Printer (np-1600m, Np1600md)	K962364	FDA 510(k)	Class II	Active
Codonics Ep-1000 Medical Color Dry Imagers	K030690	FDA 510(k)	Class II	Active
Codonics Horizon Xl Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film Imager	K060440	FDA 510(k)	Class II	Active
Codonics Np-1660 Series Medical Printers, Model 1660	K003481	FDA 510(k)	Class II	Active
Np-2600 Series Hardcopy Printers	K042232	FDA 510(k)	Class II	Active
Codonics Safe Labeling System (sls), Model 500i/500p	K101439	FDA 510(k)	Class II	Active
Codonics DirectVista Thermal Film, 1417-DVBT	1417-DVBT	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1451-DVB	1451-DVB	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1114-DVB5	1114-DVB5	EUDAMED	Class I	Active
Codonics DirectVista Paper/White Film, A4-DVP	A4-DVP	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1451-DVB5	1451-DVB5	EUDAMEDFDA UDI	Class I	Active
Horizon GS	HZGS	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVB5	810-DVB5	EUDAMED	Class I	Active
Codonics DirectVista Thermal Film, 1436-DVB	1436-DVB	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Paper/White Film, 1114-DVP	1114-DVP	EUDAMEDFDA UDI	Class I	Active
Codonics ChromaVista Paper/WhiteFilm, A-CVP	A-CVP	EUDAMEDFDA UDI	Class I	Active
SLS 500i	SLS 500i	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Paper/White Film, A-DVP	A-DVP	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVBT	810-DVBT	EUDAMEDFDA UDI	Class I	Active
SLS 600i	SLS600i	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVB	810-DVB	EUDAMED	Class I	Active
Codonics DirectVista Paper/White Film, 1417-DVP	1417-DVP	EUDAMEDFDA UDI	Class I	Active
Horizon G2	HZG2	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 810-DVC	810-DVC	EUDAMED	Class I	Active
Horizon G1	HZG1	EUDAMEDFDA UDI	Class I	Active
SLS 550i	SLS550i	EUDAMEDFDA UDI	Class I	Active
Codonics Horizon® XL Multi-media Imager	HZXL	EUDAMEDFDA UDI	Class I	Active
Virtua	Virtua	EUDAMEDFDA UDI	Class I	Active
Codonics ChromaVista Paper/WhiteFilm, A4-CVP	A4-CVP	EUDAMEDFDA UDI	Class I	Active
Codonics DirectVista Thermal Film, 1417-DVB5	1417-DVB5	EUDAMED	Class I	Active
Codonics DirectVista Thermal Film, 810-DVC	810-DVC	EUDAMED	Class I	Active
Virtua E and C	VirtuaE/C	EUDAMEDFDA UDI	Class I	Active
Codonics Direct Vista 1417 DVB	1417-DVB 500 sheets/Case	EUDAMED	Class I	Active
Codonics DirectVista Thermal Film, 1114-DVB	1114-DVB	EUDAMEDFDA UDI	Class I	Active

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