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Freedom 1

by CDR Systems Inc 7 variants

Freedom 1 (AP2) is a Class II device made by CDR Systems Inc, cleared under FDA 510(k) K122888 on 30 Apr 2013, registered in EUDAMED and listed in FDA GUDID since 8 Aug 2023 (UDI-DI 00628341930482), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122888

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00628341930482 UDI-DI Date8 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122888 Date30 Apr 2013DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K122888 decided 30 Apr 2013 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 00628341930482 listed 8 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122888
  2. Listed FDA GUDID 00628341930482

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Freedom
Generic name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
1, AP2
Primary DI / UDI-DI
00628341930482
510(k) Number
FDA product code
IYE
GMDN term
Indexed-immobilization patient positioning system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Indexed-immobilization patient positioning system

Cleared under the same submission (K122888)

and 8 more cleared under K122888

Similar devices in this category

Other devices filed under Indexed-immobilization patient positioning system.

Other devices from CDR Systems Inc

See all devices from CDR Systems Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)