# Incubator

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

- Canonical page: <https://devicerts.com/devices/incubator-i010>
- Manufacturer: [Changsha Yingtai Instrument Co., Ltd](https://devicerts.com/manufacturers/fda-fei-3030040496) (China)
- Device class: Class A (EU IVDR); Class I (US FDA)
- FDA product code: JTQ
- EMDN: W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
- GMDN: Microplate/tube/assay card incubator IVD (64818)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 06976301910413 · listed 2025-03-01 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 697630191Bio-filler5G · UDI-DI 06976301910413 · registered 2023-04-19 · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: Yingtai [FDA GUDID (AccessGUDID)]
- Generic name: Microplate/tube/assay card incubator IVD [FDA GUDID (AccessGUDID)]
- Model / reference: Bio-filler [EUDAMED, FDA GUDID (AccessGUDID)]; I010 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 06976301910413 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 697630191Bio-filler5G [EUDAMED]
- Direct marketing DI: 06976301910413 [EUDAMED]
- FDA product code: JTQ [FDA GUDID (AccessGUDID)]
- EMDN code: W02069099 [EUDAMED]
- GMDN term: Microplate/tube/assay card incubator IVD (64818) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class A [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 866.2540 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Portugal [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Professional testing: Yes [EUDAMED]
- IVD instrument: Yes [EUDAMED]
- Premarket exempt: 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 [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- Reagent: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Near-patient testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- New device: 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)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Incubator, Changsha Yingtai Instrument Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/incubator-i010 (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/incubator-i010.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/incubator-i010
- 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.