Medela

What is established and what is not

No researcher review has been written for this company yet. 8 official records from 7 official sources are on file. 6 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

• First recorded on the web archive (record type: web-presence-since) [our own observation, not an official record; status green] The web archive holds a page at this address from 1996. Shows a web archive saw a page at this address on that date. It does not show who ran the site then. checked 2026-08-03. Internet Archive (Wayback)
• 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
• 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 2026-10-20. Mail server of the company domain
• 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 2026-10-17. 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 12 medical devices: Magic InBra (K251377, 2025-09-18), Invia® Integrated Dressing (K223388, 2023-07-07), Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112, 2022-07-26) +9. 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 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. effective since 2026-10-14. OpenSanctions
• 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 2026-10-20. Domain registry record
• Operating permit for the production site (record type: operating-permit; this record does not by itself establish manufacturing) [official record; status green] Shows an authority issued a permit for an installation at this site for the activity named in the record. A permit is not an inspection report and not an observation that production is running today. effective since 2023-12-01. SHAB, Swiss Official Gazette of Commerce
• 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 2026-10-20. 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 2026-10-14. 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 2026-10-20. FDA
• 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
• 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 2026-09-07. GLEIF global LEI register (golden copy)
• Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. checked 2026-09-10. GLEIF Global LEI record

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.

Recorded in a source

• AB02-0000014687: Holds the site's permit, registry number AB02-0000014687. SHAB, Swiss Official Gazette of Commerce

Candidates, not confirmed

• medela.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)

Goods family established: Medizin- & Gesundheitsbedarf (official record of a specific product). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category Babypflege & Ernährung: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.

Check independently

• Sanctions and watchlists (OpenSanctions)