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.
브라질 보건 규제 기관인 ANVISA는 2027년 10월 23일까지 유효한 의료 기기에 대해 이 공장에 대한 유효한 우수 제조 관리 기준 인증서를 보유하고 있습니다. 인증서는 공장 자체를 검사한 후에 발급되므로 외국 규제 기관에서 이 사이트를 명명합니다. 여기서 생산된 제품은 브라질 시장에서 허용됩니다. 프로세스 번호 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
- 의료 및 건강 관리 용품
- Markets
- 오스트리아, 브라질
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.