NOVAK M PROIZVODNJA, TRGOVINA IN STORITVE D.O.O.
Slovenian industrial manufacturer and exporter
NOVAK M PROIZVODNJA, TRGOVINA IN STORITVE D.O.O. is listed by Sloexport in the other manufacturing sector. Its directory profile describes operations including Novak M is a Slovenian family-owned and worldwide oriented company, providing designed medical equipment, which helps professionals and patients bring treatment to a higher level. Since 1979, every member of the team has been striving to combine industry expertise with innovative technology. Through excellent distribut.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Komenda, Slovenia
- Website
- https://novak-m.com
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies, Industrial Machinery
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- lei-active (green), checked 2026-08-09 GLEIF
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- public-contract-awarded (green), effective since 2026-07-03 TED (Tenders Electronic Daily), EU public procurement award notices Here the award carries someone else's check: in the EU and the EEA a public buyer must exclude bidders convicted of fraud, corruption or money laundering, and those found by a final decision to owe taxes or social contributions. Directive 2014/24/EU, Article 57 (exclusion grounds)
- registry-activity (green), checked 2026-08-16 Seznam davčnih zavezancev (FURS, Finančna uprava RS)
- registry-id-verified (green), checked 2026-08-16 Poslovni register Slovenije (AJPES)
- export-registered (green), checked 2026-08-09 EU EORI validation (European Commission)
- vat-valid (green), checked 2026-08-09 VIES
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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment