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. 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

• 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 2026-08-02. Domain registry record
• First recorded on the web archive (record type: web-presence-since) [our own observation, not an official record; status green] The company website was already online in 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
• 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), Invia® Integrated Dressing (K223388, 2023), Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112, 2022) +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)
• 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)
• 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
• 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
• 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
• Legal entity ID lapsed (record type: lei-lapsed) [official record; status amber] The global finance identifier was not renewed. checked 2026-09-07. GLEIF global LEI register (golden copy)
• 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
• 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

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)

Goods family established: Perlengkapan Medis & Kesehatan (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 Perawatan & Pemberian Makan Bayi: 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

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)