Hisztopatológia Kft.
Active in EUDAMEDHungaryfrom SRN EUDAMED SRN HU-MF-000014417
- Devices
- 8
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Hisztopatológia Kft. makes
Hisztopatológia Kft. manufactures immunohistochemistry (IHC) reagent kits and solutions for detecting antibodies in tissue samples, including chromogenic substrates like DAB, AEC, and enzyme inhibitors for blocking background interference. Their portfolio includes buffers (e.g., citrate), blocking solutions, and specialized substrates for resistant staining, designed for use in diagnostic pathology workflows.
The company’s products are classified as Class A medical devices under EU regulations and are registered in the EUDAMED database. The portfolio is intended for in vitro diagnostic use and adheres to EU medical device compliance requirements.
Catalogue
Histols-Dab Ref 30014.K
Regimes: CE IVDR Registry: EUDAMEDHistols-R Ref 30011.R500
Regimes: CE IVDR Registry: EUDAMEDHistols-M Ref 30011.M500
Regimes: CE IVDR Registry: EUDAMEDHISTOLS Peroxidáz gátló oldat Ref 30013
Regimes: CE IVDR Registry: EUDAMEDHISTOLS Citrát puffer Ref 30010
Regimes: CE IVDR Registry: EUDAMEDHISTOLS BBPS Háttér gátló oldat Ref 30012
Regimes: CE IVDR Registry: EUDAMEDHistols-Mr-T Ref 30011.500T
Regimes: CE IVDR Registry: EUDAMEDHISTOLS-Rezisztens AEC Ref 30015.K
Regimes: CE IVDR Registry: EUDAMED
Company details
- EUDAMED SRN
- HU-MF-000014417
- EU VAT number
- HU11014492
- EUDAMED status
- Active
- EUDAMED registered name
- Hisztopatológia Kft.
- Registered address
- 53/1, Hungária u,, 7624, Pécs, Hungary
- Website
- www.histopat.hu
- [email protected]
- Phone
- +3672516490
- PRRC contact
- György Dr. Szekeres
Frequently asked questions
How many devices does Hisztopatológia Kft. have in the registry?
The registry currently lists 8 devices for Hisztopatológia Kft.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hisztopatológia Kft.'s devices?
Among its 8 most recently registered devices, Hisztopatológia Kft. has devices listed in EUDAMED (8 devices).
What risk classes do Hisztopatológia Kft.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Hisztopatológia Kft.'s devices are IVDR Class A. Each device page shows its own class and authorisation.
What are the newest devices from Hisztopatológia Kft. in the registry?
The most recently registered devices listed for Hisztopatológia Kft. include HISTOLS-DAB, HISTOLS-R, HISTOLS-M and HISTOLS Peroxidáz gátló oldat.