Kaneka Corporation Osaka Plant5-1-1
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, regulador sanitario brasileño, posee para esta planta un certificado de Buenas Prácticas de Fabricación válido, que abarca dispositivos médicos (programa de auditoría MDSAP), válido hasta el 10-04-2029. El certificado se emite después de una inspección de la propia planta, razón por la cual un regulador extranjero nombra este sitio: los productos fabricados aquí están permitidos en el mercado brasileño. El certificado registra la dirección del sitio como TORIKAI-NISHI, SETTSU-CITY, OSAKA 566-0072 JAPÃO. Número de proceso 25351527433201713.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Osaka, Japan
- Categories
- Suministros médicos y sanitarios
- Markets
- Japón, Brasil
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. 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. 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
- Registry ID checks out with the state register (record type: registry-link-unconfirmed) [official record; status amber] A register record with this number exists, but its link to this company is not established: the registered name or address does not confirm it. checked 2026-09-22. gBizINFO (Ministry of Economy, Trade and Industry), government-held corporate data
- Workplace on the state insurance register (record type: registry-link-unconfirmed) [official record; status amber] A register record with this number exists, but its link to this company is not established: the registered name or address does not confirm it. checked 2026-09-28. gBizINFO (Ministry of Economy, Trade and Industry), establishment records from the social insurance system
- 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)
Relationships
2 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Candidates, not confirmed
- TORIKAI-NISHI, SETTSU-CITY, OSAKA 566-0072 JAPÃO: Manufactures at the site. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- 株式会社 カネカ: Operates the site, country JP. gBizINFO (Ministry of Economy, Trade and Industry), establishment records from the social insurance system
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 legal entity's registration number and country, then check it in the official register.