Identity
- Trade Name
- HettCube FDA UDI
- Generic Name
- Automated laboratory incubator FDA UDI
- Device Name
- A mains electricity (AC-powered) device intended to provide ideal conditions for the growth of microorganisms or mammalian cells in culture by automatically monitoring and controlling temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It typically consists of multiple shelves which hold cells in culture media (e.g., in microplates, petri dishes, flasks) and may have an integrated robotic transfer arm for loading and unloading the incubator onto other instruments in a clinical or research laboratory environment. FDA UDI
- Model / Reference
- HettCube 600, 100-120V, 50/60 Hz FDA UDI
- Description
- A mains electricity (AC-powered) device intended to provide ideal conditions for the growth of microorganisms or mammalian cells in culture by automatically monitoring and controlling temperature, humidity, and gaseous conditions [e.g., carbon dioxide (CO2) and oxygen (O2) concentrations]. It typically consists of multiple shelves which hold cells in culture media (e.g., in microplates, petri dishes, flasks) and may have an integrated robotic transfer arm for loading and unloading the incubator onto other instruments in a clinical or research laboratory environment. FDA UDI
Identifiers
- Catalog Number
- 66000-01 FDA UDI
- Primary DI / UDI-DI
- 04050674074261 FDA UDI
- FDA Product Code
- JTQ FDA UDI
- GMDN Term
- Automated laboratory incubator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automated laboratory incubator
HettCube by Andreas Hettich GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automated laboratory incubator.
- Incubator — PHC CORPORATION · Class I
- Kiestra — BD Kiestra B.V. · Class A
- Kiestra — BD Kiestra B.V. · Class A
- BIOSPAG-SI — Agilent Technologies Inc. · Class I
- BIOSPA-SI — Agilent Technologies Inc. · Class I
- CO2 Incubator — Infitek Co., Ltd. · Class A
- CO2 Incubator — Infitek Co., Ltd. · Class I
- HettCube — Andreas Hettich GmbH & Co. KG · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Andreas Hettich GmbH & Co. KG
Sources (1)
- FDA UDI f69c1a78-64f1-4349-8fde-e20126586f49 34 fields · synced Jun 8, 2026