Beijing Winkonlaser Technology Limited
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.
Winkonlaser は、2012 年以来 ISO 13485 認定を受けた FDA および CE 認定のレーザー美容機器メーカーです。当社はダイオード レーザー ヘアを製造しています。
Winkonlaser は、2012 年以来、FDA および CE 承認のレーザー美容機器の ISO 13485 認定メーカーです。当社は、ダイオード レーザー脱毛機、HIFU システム、EMS 彫刻装置、CO2 フラクショナル レーザー、タトゥー除去機を製造しています。中国、米国、フランスに倉庫を構え、120カ国以上にサービスを提供しています。 OEM/ODM サービスは、世界中のクリニック、代理店、美容サロンでご利用いただけます。
- 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
- Beijing, China
- Website
- https://winkonlaser.com
- Categories
- パーソナルケア
What is established and what is not
No researcher review has been written for this company yet. 4 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
- 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 2026-08-10. Domain registry record
- Registered with the state to export across borders (record type: export-registered) [official record; status green] Required to move goods across borders. checked 2026-08-07. US FDA device establishment registration (openFDA)
- 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 2026-08-30. 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 2 medical devices: High Intensity Focused Electromagnetic Stimulation Device (FE60) (K253790, 2026), Diode Laser Hair Removal System (K241860, 2024). 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)
- Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [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)
- 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 2026-08-10. OpenSanctions
- 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 2026-08-10. Mail server of the company domain
- 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 2026-08-10. OpenSanctions
Import rules for these goods
Product-specific import rules not established for the catalog category パーソナルケア: neither the company's own description nor an official activity code shows that its own goods are of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.