Keeler Ltd.

What is established and what is not

No researcher review has been written for this company yet. 7 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

• 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 2026-09-03. FDA
• 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 2026-09-03. 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 2026-09-03. 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. checked 2026-09-03. OpenSanctions
• registry-activity (record type: registry-activity) [official record; status green] Line of business as recorded in the state register: 32500 - Manufacture of medical and dental instruments and supplies. Shows what the state itself says the company does, which you can compare with what it promises you. effective since 1946-04-18. Companies House free company data product (UK)
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 2 medical devices: KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 (K152644, 2015), Keeler Slit Lamp (K151394, 2015). 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)
• Named directors on file (record type: directors-on-file) [official record; status green] 6 directors on file. The register names the people who run the company, so there is someone answerable if something goes wrong. checked 2026-06-20. Companies House
• 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 2026-09-03. Mail server of the company domain
• On the company register (record type: registered-since) [official record; status green] On the company register since 1946-04-18. Shows how long the company has been on the state register, which is hard to fake and easy to check. effective since 1946-04-18. Companies House free company data product (UK)
• Active in the UK registry (record type: ch-active) [official record; status green] The national company register still lists it as active. checked 2026-06-20. Companies House
• 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

Claimed certifications, not confirmed by us

• ISO 9001, Quality Management IAF CertSearch
• 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: चिकित्सा एवं स्वास्थ्य देखभाल आपूर्तियाँ (registered activity code). 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 आईवियर और धूप का चश्मा: 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 9001, Quality Management certificate number, its holder and the products it covers.

• Sanctions and watchlists (OpenSanctions)