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Codonics Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000008190

Codonics Inc. is a medical device manufacturer based in the United States, with 87 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I) as of 13 Nov 2026.

Devices
87
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 74
  • EUDAMED 32
  • FDA 510(k) 7

A device listed in two registries counts in both.

Device classes
  • FDA Class II 34
  • EU Class I 31
  • FDA Class I 22
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000008190
  • DUNS 101533727

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
AR Experts B.V.NL

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.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue87

Newest first, rows 1-50 of 87

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Rows 1-50 of 87

Showing 1-50 of 87

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000008190
DUNS number
101533727
EU VAT number
980330203
EUDAMED status
Active
EUDAMED registered name
Codonics Inc.
Registered address
17991, Englewood Drive, 44130, Middleburg Heights, United States
Phone
12165701571
PRRC contact
Vince Yee(public in EUDAMED)

Frequently asked questions

How many devices does CODONICS INC. have in the registry?

The registry currently lists 87 devices for CODONICS INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list CODONICS INC.'s devices?

Among its 50 most recently registered devices, CODONICS INC. has devices listed in EUDAMED (2 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do CODONICS INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for CODONICS INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from CODONICS INC. in the registry?

The most recently registered devices listed for CODONICS INC. include Codonics Safe Label System®(SLS) 610i Point of Care Station - 170C 610i PCS, Codonics Safe Label System®(SLS) 620i Point of Care Station - 170C 620i PCS, Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C 630i PCS and Codonics Safe Label System®(SLS) 700i Point of Care Station - 170C 700i PCS.

Generated automatically from registry data and not verified by a human reviewer.