Histo 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.
ANVISA، هيئة تنظيم الصحة البرازيلية، حاصلة على شهادة ممارسات التصنيع الجيدة لهذا المصنع، والتي تغطي الأجهزة الطبية، صالحة حتى 27-11-2027. يتم إصدار الشهادة بعد فحص المصنع نفسه، ولهذا السبب قامت هيئة تنظيمية أجنبية بتسمية هذا الموقع: البضائع المصنوعة هنا مسموح بها في السوق البرازيلية. رقم العملية 25351656121202194.
- 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
- Argentina
- Categories
- اللوازم الطبية والرعاية الصحية
- Markets
- الأرجنتين, البرازيل
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 1 official record from 1 official source is 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. Nothing here confirms manufacturing, 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-09-02. OpenSanctions
- 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 2026-09-02. FDA
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.