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.
ब्राजील के स्वास्थ्य नियामक ANVISA के पास इस संयंत्र के लिए वैध गुड मैन्युफैक्चरिंग प्रैक्टिस प्रमाणपत्र है, जिसमें चिकित्सा उपकरणों को शामिल किया गया है, जो 2027-10-23 तक वैध है। प्रमाणपत्र संयंत्र के निरीक्षण के बाद ही जारी किया जाता है, यही कारण है कि एक विदेशी नियामक ने इस साइट का नाम रखा है: यहां बने सामान को ब्राजील के बाजार में अनुमति दी जाती है। प्रक्रिया क्रमांक 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
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
- Markets
- ऑस्ट्रिया, ब्राज़ील
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.