Pt Rohto Laboratories Indonesia
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, l'ente regolatore sanitario brasiliano, detiene un certificato di buona pratica di fabbricazione valido per questo impianto, che copre i dispositivi medici, valido fino al 04-09-2027. Il certificato viene rilasciato dopo un'ispezione dello stabilimento stesso, motivo per cui un regolatore straniero nomina questo sito: le merci prodotte qui sono ammesse sul mercato brasiliano. Numero di processo 25351204177201744.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Indonesia
- Categories
- Forniture medicali e sanitarie
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 5 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 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
- 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
- Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Register entry “ROHTO LABORATORIES INDONESIA”, JL. RAYA CIMAREME NO. 203. No direct link: search this name on the register page.. Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-10-16. BPOM (Indonesian Food and Drug Authority), public register of manufacturing facilities behind product registrations (Sarana)
- Trade role recorded in the register (record type: registered-trade-role) [official record; status green] The state register itself records whether the company sells wholesale, retails, or acts as an agent - not a claim the company made about itself. checked 2026-10-16. Kemenkes e-Sertifikasi Alkes (Ministry of Health of Indonesia), medical-device certification lists
- 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 2026-10-17. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- Certifications verified (record type: certs-verified) [official record; status green] Certificates were matched against the issuing register. checked 2026-10-16. Kemenkes e-Sertifikasi Alkes (Ministry of Health of Indonesia), medical-device certification lists
- product-authorised-for-sale (record type: product-authorised-for-sale; this record does not by itself establish manufacturing) [official record; status green] A national regulator lists this company as the MAKER of products it has authorised for sale in that country. It is an export footprint you can check, not a quality rating: the register says the goods were allowed in, not that they are good. checked 2026-09-24. BPOM (Indonesian Food and Drug Authority), public register of products authorised for sale in Indonesia (Cek Produk)
Relationships
1 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
- JL. RAYA CIMAREME NO. 203: Site named in the record. BPOM (Indonesian Food and Drug Authority), public register of manufacturing facilities behind product registrations (Sarana)
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)