Hemanext Inc.
United States US-MF-000021617 Last updated 23 Oct 2026
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- Devices
- 1
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Hemanext One Ref 185-0100-OUS
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Authorised representatives
About
Hemanext is a global biomedical technology pioneer in transfusion medicine. We recognize the vital role of blood for patients.
What Hemanext Inc. makes
Hemanext Inc. manufactures the Hemanext One, a device designed for blood component processing and transfusion preparation, aimed at improving patient care through optimized blood handling.
The company’s products fall under Class IIb regulatory classification and are listed in the EU’s eudamed registry. Hemanext Inc. is based in the United States.
Frequently asked questions
What types of medical devices does Hemanext Inc. manufacture?
Hemanext Inc. manufactures devices focused on transfusion medicine, specifically the Hemanext One. This device is designed for blood component processing and transfusion preparation, helping to optimize how blood is handled for patient care.
Where is Hemanext Inc. based?
Hemanext Inc. is based in the United States. The company’s headquarters and operations are located within the country, though its products may be used globally.
Which regulatory registries list Hemanext Inc.’s devices?
Hemanext Inc.’s devices, including the Hemanext One, are listed in the EU’s eudamed registry. This database is used to track medical devices authorized for sale within the European Economic Area.
How are Hemanext Inc.’s devices classified under medical device regulations?
Hemanext Inc.’s devices fall under Class IIb regulatory classification. This classification is typically assigned to devices that pose moderate risks and require special controls to ensure their safety and performance, such as those involved in blood processing and transfusion preparation.
Information
- Country
- United States
- Address
- 99, Hayden Ave, Lexington, United States
- Website
- hemanext.com
- linkedin.com/company/hemanext
- [email protected]
- Phone
- +1 781 301 7474
- PRRC contact
- Tim Burton
- EUDAMED SRN
- US-MF-000021617
- FDA FEI number
- 3044771515