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Terviseamet · 14. jaanuar 2026
Seotud ettevõtted
Bauel Grupp OÜ (adressaat)
Viit
9.3-2/26/357-1
Registreeritud
14. jaanuar 2026
Dokumendi liik
Sissetulev dokument
Adressaat
Bauel Grupp OÜ
Saabumis/saatmisviis
e-post
Funktsioon
9.3 Teenuste terviseohutus
Sari
9.3-2 Teenuste terviseohutuse alane riigisisene kirjavahetus valitsusasutuste jt riigiasutustega, juriidiliste ja füüsiliste isikutega (sh kodanike kaebused) jms
Toimik
9.3-2/2026
Vastutaja
Olga Gurjanova (TA, Peadirektori asetäitja (1) vastutusvaldkond, Keskkonnatervise osakond)
Lahendamise tähtaeg
29. jaanuar 2026

Failid

  • 📎ce diode laser.pdf332 KB
  • 📎E-kiri.eml2277 KB
  • 📎EC.pdf660 KB
  • 📎nd yag ce.pdf332 KB
  • 📎Qualification Confirmation(1).pdf333 KB

Sisu (failidest)

ECDeclarationofconformity APPLICANT: Beijing Navilaser Technology Co., Ltd # 1318,Block#5 Mei tang Huayuan,Changpin g District,102208,Beijing China HEREBYDECLARESTHATTHE PRODUCT DESCRIBED BELOW: Product Name: Diode Laser Hair Removal Machine Product Model: NDL-A,NDL-P NDL-M COMPLIES WITH THE PROVISIONS OFTHE FOLLOWING EUROPEAN DIRECTIVES: Low Votage Directive 2014/35/EU Electromagnetic Compatibi iy Dirctive 201430EU THE PRODUCT HAS BEENASSESSED BYTHEAPPLICATION OFTHE FOLLOWING STANDARDS: EN 60335-1:2012/A15:2021,EN IEC 55014-1:2021,EN IEC 55014-2:2021,EN 61000-3-2:2019+A1:2021,EN 61000-3-3:2013+A2:2021 Isue placeand date Comp a n y st u m p a n d S i g n a t ne ofauthunired persomdl Qualification Confirmation Applicant: Beijing Navilaser Technology Co. , Ltd Address:#1318 ,Block# 5Meitang Huayuan,, Changping District , Beijing China Product Name: Diode laser hair removal mahcine Fractional CO2 laser mahcine Emslimming machine Alexandrite 755nm &1064nm Nd Yag laser machine Picosecond laser machine Picosecond laser+Alexandrite machine ALL PRODUCTS OF OUR COMPANY CAN BE USED BY DOCTORS, BEAUTICIANS, ETC. Beijing Navilaser Technology Co. , Ltd Certificate – Cертификат – 證明書 – Certificat – 증명서 – ‫شهادة‬ Form QAT_10-M05, version 03, effective since June 19th, 2022 CERTIFICATE No. 0P231023.BNTCW36 Test Report / Technical Construction File no. NYQTCF102002-LVD/EMC Certificate’s Beijing Navilaser Technology Co., Ltd. Holder: # 1318, Block # 5 Meitang Huayuan, Changping District, 102208, Beijing China Certification ECM Mark Product: Nd Yag Q Switch Laser Machine Model(s): NPL-P, NPL-R, NPL-O Verification to: Standard: EN 60335-1:2012/A15:2021, EN IEC 55014-1:2021, EN IEC 55014-2:2021, EN 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 related to CE Directive(s): 2014/35/EU (Low Voltage) 2014/30/EU (Electromagnetic Compatibility) Remark: The manufacturer has voluntarily decided to submit its documents concerning the above-mentioned product for verification. Ente Certificazione Macchine confirms that the documentation made available and immediately returned to it, as containing sensitive data, meets the essential requirements of the above-mentioned directive/standard. The verification activity carried out exclusively concerned the technical documentation and no verification was carried out on the product. This document cannot replace the EC Declaration of Conformity. This document was issued in accordance with regulation RGVOL01 published on the website of www.entecerma.it and concerning voluntary certifications with a non-notified procedure. Issuance date: 23 October 2023 Expiry date: 22 October 2028 For online check: Approver Ente Certificazione Macchine Legal Representative Luca Bedonni Ente Certificazione Macchine Srl Via Ca’ Bella, 243 – Loc. Castello di Serravalle – 40053 Valsamoggia (BO) - ITALY  +39 051 6705141  +39 051 6705156  [email protected]  www.entecerma.it Saatja: [email protected] Saaja: [email protected] Teema: Fwd: EC Kuupäev: 2026-01-14 08:29 Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Tere! Käisin hiljuti tuttava salongis ning ta tutvustas mulle seal kasutusel olevat laserseadet. Seade on tõhus ja annab häid tulemusi ning väidetavalt on see kasutusel mitmetes salongides üle Euroopa. Soovin siiski enne võimaliku soetamise otsuse tegemist saada Teie ametlikku seisukohta: * Kas antud laserseadet on lubatud Eestis kasutada? * Millised on selle kasutamise tingimused ja nõuded (sh koolitus, kvalifikatsioon, järelevalve)? * Kui Saksamaal piisab kosmeetiku vastavast seadmekoolitusest, siis kas Eestis kehtivad samad või rangemad tingimused? Oman ise õe haridust, kuid olen teadlik, et osade laserseadmete kasutamine eeldab dermatoveneroloogi või muu arsti kaasamist. Bauel Grupp omab tegevusluba ambulatoorse eriarstiabi osutamisel (psühhiaatria) ja päevaravi. Sertifikaadid on kirjale lisatud. Soovin vältida olukorda, kus soetan kalli seadme, mida Eestis ei ole lubatud kasutada või mille kasutamine eeldab täiendavaid, mulle hetkel teadmata nõudeid. Palun Teie poolset hinnangut ja juhiseid. Ette tänades Lugupidamisega, Piret Leivat Bauel Grupp OÜ Tegevusluba nr L07367 Certificate – Cертификат – 證明書 – Certificat – 증명서 – ‫شهادة‬ Form QAT_10-M05, version 03, effective since June 19th, 2022 CERTIFICATE No. 0P231023.BNTCW40 Test Report / Technical Construction File no. DLHTCF102001-LVD/EMC Certificate’s Beijing Navilaser Technology Co., Ltd. Holder: # 1318, Block # 5 Meitang Huayuan, Changping District, 102208, Beijing China Certification ECM Mark Product: Diode Laser Hair Removal Machine Model(s): NDL-A, NDL-P, NDL-R Verification to: Standard: EN 60335-1:2012/A15:2021, EN IEC 55014-1:2021, EN IEC 55014-2:2021, EN 61000-3-2:2019+A1:2021, EN 61000-3-3:2013+A2:2021 related to CE Directive(s): 2014/35/EU (Low Voltage) 2014/30/EU (Electromagnetic Compatibility) Remark: The manufacturer has voluntarily decided to submit its documents concerning the above-mentioned product for verification. Ente Certificazione Macchine confirms that the documentation made available and immediately returned to it, as containing sensitive data, meets the essential requirements of the above-mentioned directive/standard. The verification activity carried out exclusively concerned the technical documentation and no verification was carried out on the product. This document cannot replace the EC Declaration of Conformity. This document was issued in accordance with regulation RGVOL01 published on the website of www.entecerma.it and concerning voluntary certifications with a non-notified procedure. Issuance date: 23 October 2023 Expiry date: 22 October 2028 For online check: Approver Ente Certificazione Macchine Legal Representative Luca Bedonni Ente Certificazione Macchine Srl Via Ca’ Bella, 243 – Loc. Castello di Serravalle – 40053 Valsamoggia (BO) - ITALY  +39 051 6705141  +39 051 6705156  [email protected]  www.entecerma.it
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