Lake Region Medical

Listed in a source registry

ANVISA (Brazilian Health Regulatory Agency) open data

What is established and what is not

No researcher review has been written for this company yet. 12 official records from 8 official sources are on file. 2 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 2026-09-02. FDA
• 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 2026-09-02. OpenSanctions
• 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 2026-09-02. OpenSanctions
• Listed in a source registry (record type: listed-in-registry) [official record; status amber] Listed in The Companies Registration Office – an Oifig um Chlarú Cuideachtaí; entry number 191297. Matched to this company by name only; no second anchor confirms it is the same legal entity.. Found in a named public register, not only on its own website. checked 2026-09-02. BRIS, EU business registers interconnection (e-justice.europa.eu)
• Registered with the U.S. FDA as a Contract Manufacturer (record type: fda-contract-manufacturer) [official record; status green] Registered as making goods for other brands. checked 2026-09-02. FDA
• Authorised Economic Operator in the EU customs register (record type: aeo-certified) [official record; status green] Customs granted trusted-trader status after auditing its procedures. checked 2026-08-30. EU AEO register (European Commission)
• 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)
• manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-17. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
• Annual accounts filed with the register (record type: annual-accounts-filed) [official record; status green] Indicates the company still meets its reporting duties. checked 2026-09-07. Companies Registration Office (CRO), Ireland
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 4 medical devices: Enroute 0.014'' Transcarotid Guidewire (K253746, 2026-03-19), ENROUTE 0.014 Guidewire (K160643, 2016-10-18), HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE (K140536, 2014-12-17) +1. 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)
• 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 2026-09-07. Companies Registration Office (CRO), Ireland
• On the company register (record type: registered-since) [official record; status green] Shows how long the company has been on the state register, which is hard to fake and easy to check. checked 2026-09-07. Companies Registration Office (CRO), Ireland
• 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. Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados
• registry-activity (record type: registry-activity) [official record; status green] Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-09-07. Companies Registration Office (CRO), Ireland

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.

Recorded in a source

• PARKMORE WEST BUSIMESS PARK, ORANMORE - GALWAY: Manufactures at the site. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)

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

• Sanctions and watchlists (OpenSanctions)