Cefla S.C.
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.
Cefla è un produttore cooperativo italiano di apparecchiature odontoiatriche, sistemi di arredo negozi e industria...
No description from the company. The catalog line you may see elsewhere is generated by us from the category and location, not a statement by the company.
- 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
- Imola, Italy
- Founded
- 1932 (as stated by the company, not confirmed by a state register)
- Website
- cefla.com
- Categories
- Forniture medicali e sanitarie, Macchinari industriali, Forniture e attrezzature dentali
- Markets
- Italia, Germania, Stati Uniti, Francia, Regno Unito, Cina, Brasile
What is established and what is not
No researcher review has been written for this company yet. 2 official records from 2 official sources are on file. 5 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
- 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
- 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
- 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-08. OpenSanctions
- 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 2026-08-08. 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-08. OpenSanctions
- Active legal entity ID (LEI) (record type: lei-active-by-name) [our own observation, not an official record; status green] A search of the GLEIF register by company name found an active identifier under this name. The match is by name only, so it may belong to another legal entity. checked 2026-08-08. GLEIF
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 6 medical devices: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, (K230895, 2024), Apex Locator (K231990, 2024), NewTom 7G (K220664, 2022) +3. 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)
Profiles
Claimed certifications, not confirmed by us
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 14001, Environmental Management 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: Forniture medicali e sanitarie (official record of a specific product), Forniture e attrezzature dentali (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 Macchinari industriali: 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.