Abionic 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.
Abionic
PSP cleared for Pediatric use PSP can now support early Sepsis detection from neonates to adults, empowering caregivers to trigger the optimal treatment protocols without delay! Early Sepsis Detection Across Hospital Workflows Sepsis is a time-sensitive emergency requiring rapid Rule-in. Emergency and Critical care settings need solutions that enable sepsis detection earlier than the Standard of Care. The Pancreatic Stone Protein (PSP) biomarker, measured exclusively on the abioSCOPE®, empowers caregivers to DETECT Sepsis & ACTIVATE bundles within minutes. More... abioSCOPE® The abioSCOPE®, a near-patient rapid diagnostic platform, integrates seamlessly into clinical workflows and delivers lab-quality results from a drop of blood within minutes, providing valuable clinical insights. More..
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Epalinges, Switzerland
- Website
- https://abionic.com
- Categories
- Medical & Healthcare Supplies
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 5 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
- 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 2026-08-22. Mail server of the company domain
- 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 2026-08-22. Domain registry record
- 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. checked 2026-08-22. 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 2026-08-22. FDA
- Legally registered and still active (record type: registry-active-global) [official record; status green] Shows the register lists the registration as active on the date we read it. It does not show how busy the business is. checked 2026-08-22. Zefix (Swiss commercial registry)
- 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 2026-08-22. OpenSanctions
- Legal entity ID lapsed (record type: lei-lapsed) [official record; status amber] The global finance identifier was not renewed. This does not mean the company closed. checked 2026-08-22. GLEIF
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 1 medical devices: IVD CAPSULE PSP; abioSCOPE (K240041, 2024-09-25). 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)
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
- abionic.com: Website of this business. Source record
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)