# LED Shadowless Operating Light

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

- Canonical page: <https://devicerts.com/devices/led-shadowless-operating-light-creled-3300>
- Manufacturer: [Shandong Lewin Medical Equipment Co., Ltd.](https://devicerts.com/manufacturers/shandong-lewin-medical-equipment-co-ltd) (China)
- Device class: Class I (EU MDR); Class II (US FDA)
- FDA product code: FTD
- EMDN: Z12010701 FIXED SCIALYTIC LAMPS
- GMDN: Operating room light (12282)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 69760416142VQ · UDI-DI 06976041611069 · registered 2023-12-14 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 06976041611069 · listed 2023-02-08 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: LEWIN [FDA GUDID (AccessGUDID)]
- Generic name: Operating room light [FDA GUDID (AccessGUDID)]
- Device name: LED Shadowless Operating Light [EUDAMED]
- Model / reference: CreLed 3300 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 06976041611069 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 69760416142VQ [EUDAMED]
- FDA product code: FTD [FDA GUDID (AccessGUDID)]
- EMDN code: Z12010701 [EUDAMED]
- GMDN term: Operating room light (12282) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 878.4580 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Poland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: No [EUDAMED]; Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: 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]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- 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)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: LED Shadowless Operating Light, Shandong Lewin Medical Equipment Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/led-shadowless-operating-light-creled-3300 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/led-shadowless-operating-light-creled-3300.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/led-shadowless-operating-light-creled-3300
- 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.