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Indexing Bar

by CDR Systems Inc.

Ref IB06 SeriesModel FreedomX / Equilibrium / SaBella Flex Series, IB06 Indexing Bar Series

Indexing Bar (IB06 Series) is a device classified as Class I in the EU and Class II in the US made by CDR Systems Inc, registered in EUDAMED on 6 May 2026 (Basic UDI-DI 62834193018B), cleared under FDA 510(k) K122888 on 30 Apr 2013 and listed in FDA GUDID since 31 Dec 2019 (UDI-DI 00628341930147), active as of 22 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 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number62834193018B Basic UDI-DI 00628341930147UDI-DIDate6 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628341930147 UDI-DI Date31 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122888 Date30 Apr 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 62834193018B registered 6 May 2026 Active
  • FDA 510(k) K122888 decided 30 Apr 2013 Active
  • FDA GUDID UDI-DI 00628341930147 listed 31 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122888
  2. Listed FDA GUDID 00628341930147
  3. Registered EUDAMED 62834193018B

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  • Withdrawn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
Indexing Bar EUDAMED
Freedom™ Indexing Bar EUDAMED
Index Bar GUDID
Generic name
Indexed-immobilization patient positioning system
Device name
Precision Patient Positioning Systems
Model / Ref / Catalog
FreedomX / Equilibrium / SaBella Flex Series EUDAMED
IB06 Series EUDAMED
IB06 Indexing Bar Series EUDAMED
1 GUDID
IB06 GUDID
Primary DI / UDI-DI
00628341930147
Basic UDI-DI
62834193018B, 62834193368W
510(k) Number
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Indexed-immobilization patient positioning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FreedomX / Equilibrium / SaBella Flex Series
IB06 Series
IB06 Indexing Bar Series
GUDID
1
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CA-MF-000051790
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from CDR Systems Inc

See all devices from CDR Systems Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)