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HettCube
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 64000-01Model 62000, 62005, 64000, 64005, 66000, 66005
Identity
- Trade Name
- HettCube 400, 100-120V, 50/60 Hz EUDAMEDHettCube FDA UDI
- Generic Name
- Automated laboratory incubator FDA UDI
- Device Name
- HettCube EUDAMEDA 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
- 62000, 62005, 64000, 64005, 66000, 66005 EUDAMED64000-01 EUDAMEDHettCube 400, 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
- 64000-01 FDA UDI
- Primary DI / UDI-DI
- 04050674074254 EUDAMEDFDA UDI
- Basic UDI-DI
- 04050674090001CA EUDAMED
- Direct Marketing DI
- 04050674074254 EUDAMED
- FDA Product Code
- JTQ FDA UDI
- EMDN Code
- W02039002 CARBON DIOXIDE INCUBATORS EUDAMED
- GMDN Term
- Automated laboratory incubator FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2540 FDA UDI
- Market of Registration
- Germany 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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 — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| 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 (2)
- FDA UDI d2bc0a0a-d5b6-438a-94df-af35fac64ef9 34 fields · synced Jul 14, 2026
- EUDAMED 7551c998-0477-48d7-8d31-f2aa902f31ce 61 fields · synced Jul 14, 2026