I.T.S. Gmbh
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
ANVISA, brazylijski organ regulacyjny ds. zdrowia, posiada dla tego zakładu ważny certyfikat Dobrej Praktyki Produkcyjnej, obejmujący wyroby medyczne, ważny do 23.10.2027 r. Certyfikat wydawany jest po inspekcji samego zakładu, dlatego zagraniczny organ regulacyjny nadaje tej witrynie nazwę: towary tu wyprodukowane są dopuszczone do obrotu na rynku brazylijskim. Numer procesu 25351354894201637.
- Type
- Not established by any record (our catalog import lists it as manufacturer; that is not evidence of the role)
- Role
- Role not established by any record
- Location
- Austria
- Categories
- Artykuły medyczne i związane z opieką zdrowotną
- Markets
- Austria, Brazylia
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 3 official records from 3 official sources are on file. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. Nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Legal entity ID lapsed (record type: lei-lapsed) [official record; status amber] The global finance identifier was not renewed. checked 2026-09-07. GLEIF global LEI register (golden copy)
- Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-08-24. FDA
- Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
Check independently
Before a first order, ask for the production site address and a document linking that site to this legal entity.