# Bilisoft 2.0 009791

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

- Canonical page: <https://devicerts.com/devices/bilisoft-2-0-009791>
- Manufacturer: [Lumitex, Inc.](https://devicerts.com/manufacturers/lumitex-inc) (United States, FDA 510(k) applicant)
- Device class: Class IIa (EU MDD); Class II (US FDA)
- FDA product code: LBI
- EMDN: Z12080401 PAEDIATRIC PHOTOTHERAPY EQUIPMENT
- GMDN: Blanket/pad infant phototherapy unit (33791)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00812432020453 · UDI-DI 00812432020453 · registered 2026-06-30 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00812432020453 · listed 2018-11-15 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K053568 · decision 2006-04-17 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: Bilisoft 2.0 [FDA GUDID (AccessGUDID)]
- Generic name: Blanket/pad infant phototherapy unit [FDA GUDID (AccessGUDID)]
- Model / reference: BiliSoft 2.0 PT Systems [EUDAMED]; Small Pad [EUDAMED]; English [EUDAMED]; US Plug [EUDAMED]; 2103121-001 [EUDAMED]; 009791 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00812432020453 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00812432020453 [EUDAMED]
- 510(k) Number: K053568 [FDA GUDID (AccessGUDID)]
- FDA product code: LBI [FDA GUDID (AccessGUDID)]
- EMDN code: Z12080401 [EUDAMED]
- GMDN term: Blanket/pad infant phototherapy unit (33791) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 880.5700 [FDA GUDID (AccessGUDID)]
- System or procedure pack: System which is a device in itself [EUDAMED]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [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]
- 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]
- 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: Bilisoft 2.0 009791, Lumitex, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/bilisoft-2-0-009791 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/bilisoft-2-0-009791.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/bilisoft-2-0-009791
- 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.