Immunodiagnostic Systems SA
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.
In-Vitro Medical Diagnostics & Immunoassays | IDS PLC
우리는 임상 및 연구 실험실 시장에 선도적인 체외 진단 솔루션 제공업체입니다. 30년 이상의 전문 지식을 바탕으로 당사는 혁신적이고 고품질의 면역분석법 및 장비를 개발(사내), 제조 및 판매하고 있습니다.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Liege, Belgium
- Website
- https://www.idsplc.com
- Categories
- 의료 및 건강 관리 용품
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. 4 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
- Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. effective since 2026-08-17. US FDA device establishment registration (openFDA)
- Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-14. Domain registry record
- 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 2026-08-14. 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 2026-08-14. OpenSanctions
- Registered with the U.S. FDA as a Contract Manufacturer (record type: fda-contract-manufacturer) [official record; status green] Registered as making goods for other brands. checked 2026-08-14. FDA
- Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-14. Mail server of the company domain
- 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 2026-08-14. FDA
- Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
- 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
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
- Rue Ernest Solvay 101, 4000, Liège: Holds the site's permit, registry number BE 705/0197. TRACES NT, European Commission register of approved establishments (DG SANTE)
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)