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LEPS™ baseplate LEPSBP

by Macromedics B.V.

Ref 130200

LEPS baseplate LEPSBP (130200) is an indexed-immobilization patient positioning system (EU MDR Class I; FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Macromedics B.V., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 872016816130300HB) and listed in FDA GUDID since 31 Dec 2016 (UDI-DI 08719425702322), 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 Number872016816130300HB Basic UDI-DI 08719425702322UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719425702322 UDI-DI Date31 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 872016816130300HB registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 08719425702322 listed 31 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08719425702322
  2. Registered EUDAMED 872016816130300HB

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  • Withdrawn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
LEPS™ baseplate
Generic name
Indexed-immobilization patient positioning system
Device name
Leps
Model / Ref / Catalog
130200, LEPSBP
Primary DI / UDI-DI
08719425702322
Basic UDI-DI
872016816130300HB
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 Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
130200
GUDID
LEPSBP
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)