# LEPS™ baseplate LEPSBP

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/leps-baseplate-130200>
- Manufacturer: [Macromedics B.V.](https://devicerts.com/manufacturers/macromedics-b-v) (FDA registration: United States)
- Device class: Class I (EU MDR); Class II (US FDA)
- FDA product code: IYE
- EMDN: Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES
- GMDN: Indexed-immobilization patient positioning system (40897)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 872016816130300HB · UDI-DI 08719425702322 · registered 2026-07-02 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 08719425702322 · listed 2016-12-31 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: LEPS™ baseplate [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Indexed-immobilization patient positioning system [FDA GUDID (AccessGUDID)]
- Device name: LEPS [EUDAMED]
- Model / Ref / Catalog: 130200 [EUDAMED, FDA GUDID (AccessGUDID)]; LEPSBP [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08719425702322 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 872016816130300HB [EUDAMED]
- FDA product code: IYE [FDA GUDID (AccessGUDID)]
- EMDN code: Z12011280 [EUDAMED]
- GMDN term: Indexed-immobilization patient positioning system (40897) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.5050 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- MRI safety: MR Safe [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: LEPS™ baseplate LEPSBP, Macromedics B.V. deviCERTS medical device catalogue. https://devicerts.com/devices/leps-baseplate-130200 (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/leps-baseplate-130200.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/leps-baseplate-130200
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.