Themis Pathology
Active in EUDAMEDRomaniafrom SRN EUDAMED SRN RO-MF-000023578
- Devices
- 5
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
Catalogue
Lumea BxBoard Ref BxBoard General
BxCamera Ref TECH-KIT-0004
LUMEA BxChip Ref BxC 001.b
LUMEA BxChip Ref BxC 001s.b
LUMEA BxChip Ref BxC 012.b
Company details
- EUDAMED SRN
- RO-MF-000023578
- EU VAT number
- RO30886031
- EUDAMED status
- Active
- EUDAMED registered name
- Themis Pathology
- EUDAMED abbreviated name
- Themis
- Registered address
- 31-31, Drumul Intre Tarlale, 032982, Bucuresti, Romania
- Website
- lumeadigital.com
- linkedin.com/company/lumea
- [email protected]
- Phone
- +40722738373
- PRRC contact
- Andronache Daniel
From the company website
Lumea is the U.S. leader in primary clinical digital pathology, processing the highest volume of primary digital diagnoses nationwide. Founded by Stanford-trained pathologist Dr. Matthew Leavitt, Lumea's fully integrated platform combines FDA-cleared diagnostic software (Viewer+), proprietary tissue-handling technology (BxBoard, BxChip, BxCamera), an all-in-one digital pathology LIS (BxLink), and an open AI ecosystem — all in one diagnostic workspace. Lumea supports over 40% of the U.S. outpatient prostate cancer market and serves leading dermatology and gastroenterology practices across the country, with a presence spanning five continents. Recognized by Inc. 5000, Utah Best of State for Medical Innovation, and Global Health & Pharma as Healthcare Tech Innovator of the Year.
What Themis Pathology makes
Themis Pathology manufactures digital pathology tissue-handling devices, including the LUMEA BxChip, which is designed for processing and preparing tissue samples for diagnostic analysis. These products are intended for use in pathology workflows to support digital imaging and examination of biopsy specimens.
The company’s devices are classified as Class A under EU regulations and are listed in the eudamed database. Themis Pathology operates as a medical device manufacturer based in Romania.
Frequently asked questions
How many devices does Themis Pathology have in the registry?
The registry currently lists 5 devices for Themis Pathology. Devices recorded under merged duplicate company entries are counted once.
Which registries list Themis Pathology's devices?
Among its 5 most recently registered devices, Themis Pathology has devices listed in EUDAMED (5 devices).
What risk classes do Themis Pathology's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Themis Pathology's devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Themis Pathology in the registry?
The most recently registered devices listed for Themis Pathology include Lumea BxBoard, BxCamera and LUMEA BxChip.