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CDR Systems Inc

Active in EUDAMED

Canadafrom SRN EUDAMED SRN CA-MF-000051790

CDR Systems Inc is a medical device manufacturer based in Canada, with 180 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I; FDA Class II) as of 14 Nov 2026.

Devices
180
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • EUDAMED 165
  • FDA GUDID 45
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class I 150
  • FDA Class II 30
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN CA-MF-000051790
  • DUNS 206950904

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
Advena LimitedMT

What CDR Systems Inc makes

CDR Systems Inc manufactures indexed-immobilization patient positioning systems, such as the Freedom, Sabella Flex, and Prone Breast systems, alongside various index bars. The company also produces reusable and single-use radiation therapy bolus products, including gel film bolus options.

The company is based in Canada, and its portfolio includes devices categorized as Class I and Class II. These products are listed in the FDA 510(k) and UDI databases, as well as the EUDAMED registry.

AI-generated from registry data, 25 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue180

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
CA-MF-000051790
DUNS number
206950904
EUDAMED status
Active
EUDAMED registered name
CDR Systems Inc.
Registered address
4334 - 110, Ave SE, T2C 0J6, Alberta, Canada
Website
www.cdrsys.ca
Phone
1.403.850.7035
PRRC contact
Ivan Leung(public in EUDAMED)

Frequently asked questions

How many devices does CDR Systems Inc have in the registry?

The registry currently lists 180 devices for CDR Systems Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list CDR Systems Inc's devices?

Among its 50 most recently registered devices, CDR Systems Inc has devices listed in EUDAMED (50 devices).

What risk classes do CDR Systems Inc's devices fall under?

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

What are the newest devices from CDR Systems Inc in the registry?

The most recently registered devices listed for CDR Systems Inc include SaBella Flex Dual Axis Precision Positioning Overlay Only, Thermoplastic Immobilization Materials (CDR), Wedges, Supports & Positioning Aids and Procline.

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