GN Hearing A/S

Listed in a source registry

US FDA device registration and listing (open.fda.gov)

What is established and what is not

No researcher review has been written for this company yet. 12 official records from 11 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

• Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 2 public contracts on record, the latest awarded 2025-01-17. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2025-01-17. TED (Tenders Electronic Daily), EU public procurement award notices 在这里，中标还附带了别人做过的审查：在欧盟和欧洲经济区，公共采购方必须排除因欺诈、腐败或洗钱被定罪的投标人，以及经终局裁决认定拖欠税款或社会保险费的投标人。 这项审查只针对那次招标、截至授标之日：它不说明公司今天的状况，中标也不说明合同已经履行。 Directive 2014/24/EU, Article 57 (exclusion grounds)
• EAEU product declaration on record, company's role not established (record type: eaeu-product-declaration-party; this record does not by itself establish manufacturing) [official record; status green] An official EAEU register holds a declaration for specific goods that names this company; the record we hold does not say in which role (manufacturer, applicant or representative). It shows those products may be sold on the EAEU market, not a general quality mark. Paste the document number into the register search to see the record. checked 2026-08-16. EAEU unified register of certificates and declarations
• 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)
• 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 2026-09-07. Registre national des producteurs (ADEME/SYDEREP), France
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 5 medical devices: Jabra Enhance Select Self-fit (Jabra Enhance Select 550) (K254108, 2026), Jabra Enhance Plus (K213424, 2022), Tinnitus Sound Generator Module (K193303, 2020) +2. 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)
• Annual accounts filed with the register (record type: annual-accounts-filed) [official record; status green] Indicates the company still meets its reporting duties. checked 2026-09-23. Erhvervsstyrelsen, offentliggjorte årsrapporter (virk.dk)
• Site address listed in a government regulator's register (record type: facility-registered) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. checked 2026-08-07. US FDA device establishment registration (openFDA)
• 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
• 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
• Listed in a source registry (record type: listed-in-registry) [official record; status amber] Listed in Erhvervsstyrelsen; entry number 55082715. 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)
• 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
• 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
• 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

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)