FOTONA proizvodnja optoelektronskih naprav d.d.
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
スロベニアの工業製造業者および輸出業者
FOTONA プロイズヴォドニャ オプトエレクトロンスキー ナプラブ D.D. Sloexport によりその他の製造部門に上場されています。そのディレクトリ プロファイルには、皮膚科、婦人科、歯科用の医療レーザー システムの製造などの業務が記載されています。
- Type
- Not established by any record (our catalog import lists it as manufacturer; that is not evidence of the role)
- Role
- Role not established by any record
- Location
- Ljubljana, Slovenia
- Founded
- 1964 (as stated by the company, not confirmed by a state register)
- Website
- https://fotona.com
- Categories
- 医薬品製造, 医療およびヘルスケア用品
- Markets
- スロベニア, オーストリア, ドイツ, イタリア, クロアチア
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 3 official records from 3 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. Nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- 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 2026-08-08. 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 2026-08-08. 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 2026-08-08. Domain registry record
- 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 2026-08-08. Mail server of the company domain
- Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-08-23. GLEIF global LEI register (golden copy)
- Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 1 public contracts on record, the latest awarded 2024-03-06. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2024-03-06. TED (Tenders Electronic Daily), EU public procurement award notices ここでの落札は、他者による審査も伴います。EUおよびEEAでは、公共調達者は詐欺、汚職、資金洗浄で有罪となった入札者、および確定した決定で税や社会保険料の未納が認定された入札者を排除しなければなりません。 この審査はその入札の落札日時点のものです。会社の現在の状況を示すものではなく、落札は契約が履行されたことを示すものでもありません。 Directive 2014/24/EU, Article 57 (exclusion grounds)
- 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)
Goods family established: 医療およびヘルスケア用品 (the company's own text). 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 医薬品製造: 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 production site address and a document linking that site to this legal entity.