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Sabella Flex 1

by CDR Systems Inc

Ref SBS14-K SeriesModel SBS14 MR Conditional SaBella Flex Series

Sabella Flex 1 (SBS14-K) 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 21 May 2026 (Basic UDI-DI 62834193318L), cleared under FDA 510(k) K122888 on 30 Apr 2013 and listed in FDA GUDID since 31 Dec 2019 (UDI-DI 00628341930260), 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
European UnionCE/MDR EUDAMED Number62834193318L Basic UDI-DI 00628341930260UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628341930260 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 62834193318L registered 21 May 2026 Active
  • FDA 510(k) K122888 decided 30 Apr 2013 Active
  • FDA GUDID UDI-DI 00628341930260 listed 31 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122888
  2. Listed FDA GUDID 00628341930260
  3. Registered EUDAMED 62834193318L

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  • Withdrawn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
SaBella Flex (MR Conditional) EUDAMED
Sabella Flex GUDID
Generic name
Indexed-immobilization patient positioning system
Model / Ref / Catalog
SBS14 MR Conditional SaBella Flex Series EUDAMED
SBS14-K Series EUDAMED
1 GUDID
SBS14-K GUDID
Primary DI / UDI-DI
00628341930260
Basic UDI-DI
62834193318L
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
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SBS14 MR Conditional SaBella Flex Series
SBS14-K 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.

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 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)