Identity
- Trade Name
- Yingtai FDA UDI
- Generic Name
- Microplate/tube/assay card incubator IVD FDA UDI
- Device Name
- Incubator EUDAMEDIncubator is a temperature-controlled device specifically designed for the cultivation and experimentation of biological samples. It is primarily used for the incubation and cultivation of cells, microorganisms, and biological specimens, and is widely applied in fields such as molecular biology, medical research, food testing, and biotechnology. The device provides an optimal growth environment for samples through precise temperature control and humidity regulation. FDA UDI
- Model / Reference
- FYQ-100 EUDAMEDFDA UDII001 EUDAMED
- Description
- Incubator is a temperature-controlled device specifically designed for the cultivation and experimentation of biological samples. It is primarily used for the incubation and cultivation of cells, microorganisms, and biological specimens, and is widely applied in fields such as molecular biology, medical research, food testing, and biotechnology. The device provides an optimal growth environment for samples through precise temperature control and humidity regulation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976301910321 EUDAMEDFDA UDI
- Basic UDI-DI
- 697630191FYQ-100P3 EUDAMED
- Direct Marketing DI
- 06976301910321 EUDAMED
- FDA Product Code
- JTQ FDA UDI
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microplate/tube/assay card incubator IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2540 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Incubator by Changsha Yingtai Instrument Co., Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697630191FYQ-100P3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Changsha Yingtai Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000034851
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 84c6dbed-7953-40f9-b59f-66689c4c847b 61 fields · synced Jul 29, 2026
- FDA UDI ba606406-e8af-418d-a5c2-3e0444e5cd62 33 fields · synced May 30, 2026