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FlexBoard™ BTM-SX FB-BTMSX

by Macromedics B.V.

Part of a family of 32 devices: see the family page

Ref 174630

FlexBoard™ BTM-SX FB-BTMSX (174630) is a device classified as Class I in the EU and Class II in the US made by Macromedics B.V., registered in EUDAMED on 17 Jul 2026 (Basic UDI-DI 872016816122500HQ) and listed in FDA GUDID since 21 Apr 2023 (UDI-DI 08720168160744), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number872016816122500HQ Basic UDI-DI 08720168160744UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08720168160744 UDI-DI Date21 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 872016816122500HQ registered 17 Jul 2026 Active
  • FDA GUDID UDI-DI 08720168160744 listed 21 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08720168160744
  2. Registered EUDAMED 872016816122500HQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
FlexBoard™ BTM-SX
Generic name
Indexed-immobilization patient positioning system
Device name
BreastBoard
Model / Ref / Catalog
174630, FB-BTMSX
Primary DI / UDI-DI
08720168160744
Basic UDI-DI
872016816122500HQ
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
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
174630
GUDID
FB-BTMSX
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

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Macromedics B.V.

See all devices from Macromedics B.V. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)