SCHILLER

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. 3 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

• Certificates named on their own site (record type: certificate-page-on-site; this record does not by itself establish manufacturing) [stated or published by the company, not an official record; status amber] Shows where the company itself claims the certificate, so you can open that page and judge it. checked 2026-08-11. Company's own certification page
• 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 2026-07-21. FDA
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 16 medical devices: medilogFD (K253562, 2026-08-14), ARGUS PB-3000 (K221056, 2023-07-06), CARDIOVIT AT-102 G2 (K183425, 2020-03-02) +13. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
• 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 2026-07-21. OpenSanctions
• Legally registered and still active (record type: registry-active-global) [official record; status green] Indicates the company is not dissolved or winding down. checked 2026-07-21. Zefix (Swiss commercial registry)
• Legal entity ID lapsed (record type: lei-lapsed-by-name) [our own observation, not an official record; status amber] A search of the GLEIF register by company name found an identifier under this name that was not renewed. The match is by name only, so it may belong to another legal entity. checked 2026-07-21. GLEIF
• Places goods on the market (national producer register) (record type: places-goods-on-market; this record does not by itself establish manufacturing) [official record; status green] A state register lists this company as placing these goods on the market, as their maker or importer. By itself it does not show who makes them. checked 2026-10-03. Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
• 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. Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices

Claimed certifications, not confirmed by us

• ISO 13485, Medical Devices Quality IAF CertSearch
• CE Marking EU NANDO (notified bodies)

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 ISO 13485, Medical Devices Quality certificate number, its holder and the products it covers.

• Sanctions and watchlists (OpenSanctions)