Promedon S.A.
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 चिकित्सा उपकरणों को कवर करने वाले इस संयंत्र के लिए वैध गुड मैन्युफैक्चरिंग प्रैक्टिस प्रमाणपत्र है, जो 2027-01-13 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। प्रमाणपत्र साइट का पता AV के रूप में दर्ज करता है। जनरल मैनुअल सेवियो एस/एन, लोटे 3, मंज़ाना 3, पार्के इंडस्ट्रियल फ़ेरेरा 5000, कॉर्डोबा - कॉर्डोबा/अर्जेंटीना। प्रक्रिया क्रमांक 25351064306201953।
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Cordoba, Argentina
- Categories
- चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ
- Markets
- अर्जेंटीना, ब्राज़ील
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 4 official records from 4 official sources are on file. 2 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-09-02. OpenSanctions
- No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-09-02. OpenSanctions
- 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 2026-08-21. Taxpayer status file (Constancia de inscripcion)
- manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- Active taxpayer registration (record type: tax-filing-active) [official record; status green] Registered as an active taxpayer. checked 2026-09-26. ARCA (Argentine tax authority), full taxpayer status file (Constancia de inscripcion, RG 1817)
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)