| Dokumendiregister | Terviseamet |
| Viit | 9.3-2/26/357-1 |
| Registreeritud | 14.01.2026 |
| Sünkroonitud | 15.01.2026 |
| Liik | Sissetulev dokument |
| 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 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Bauel Grupp OÜ |
| Saabumis/saatmisviis | Bauel Grupp OÜ |
| Vastutaja | Olga Gurjanova (TA, Peadirektori asetäitja (1) vastutusvaldkond, Keskkonnatervise osakond) |
| Originaal | Ava uues aknas |
|
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
EC Declaration of conformity
APPLICANT:
Beijing Navilaser Technology Co., Ltd
# 1318,Block#5 Meitang Huayuan,Changping District,102208,Beijing China
HEREBYDECLARESTHATTHE PRODUCT DESCRIBED BELOW:
COMPLIES WITH THE PROVISIONS OFTHE FOLLOWING EUROPEAN DIRECTIVES:
Low Votage Directive 2014/35/EU
Electromagnetic Compatibi iy Dirctive 201430E
Product Name: Diode Laser Hair Removal Machine
Product Model: NDL-A,NDL-P NDL-M
U
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 Company stumpand Signatne
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
Form QAT_10-M05, version 03, effective since June 19th, 2022
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 C e
rt if ic
a te
– C
е р
ти ф
и к а
т – 證 明 書
– C
e rt
if ic
a t
– 증 명 서
– ة
اد شه
CERTIFICATE
No. 0P231023.BNTCW40
Test Report / Technical Construction File no. DLHTCF102001-LVD/EMC
Certificate’s
Holder:
Beijing Navilaser Technology Co., Ltd. # 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
Form QAT_10-M05, version 03, effective since June 19th, 2022
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 C e
rt if ic
a te
– C
е р
ти ф
и к а
т – 證 明 書
– C
e rt
if ic
a t
– 증 명 서
– ة
اد شه
CERTIFICATE
No. 0P231023.BNTCW36
Test Report / Technical Construction File no. NYQTCF102002-LVD/EMC
Certificate’s
Holder:
Beijing Navilaser Technology Co., Ltd. # 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
EC Declaration of conformity
APPLICANT:
Beijing Navilaser Technology Co., Ltd
# 1318,Block#5 Meitang Huayuan,Changping District,102208,Beijing China
HEREBYDECLARESTHATTHE PRODUCT DESCRIBED BELOW:
COMPLIES WITH THE PROVISIONS OFTHE FOLLOWING EUROPEAN DIRECTIVES:
Low Votage Directive 2014/35/EU
Electromagnetic Compatibi iy Dirctive 201430E
Product Name: Diode Laser Hair Removal Machine
Product Model: NDL-A,NDL-P NDL-M
U
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 Company stumpand Signatne
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
Form QAT_10-M05, version 03, effective since June 19th, 2022
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 C e
rt if ic
a te
– C
е р
ти ф
и к а
т – 證 明 書
– C
e rt
if ic
a t
– 증 명 서
– ة
اد شه
CERTIFICATE
No. 0P231023.BNTCW40
Test Report / Technical Construction File no. DLHTCF102001-LVD/EMC
Certificate’s
Holder:
Beijing Navilaser Technology Co., Ltd. # 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
Form QAT_10-M05, version 03, effective since June 19th, 2022
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 C e
rt if ic
a te
– C
е р
ти ф
и к а
т – 證 明 書
– C
e rt
if ic
a t
– 증 명 서
– ة
اد شه
CERTIFICATE
No. 0P231023.BNTCW36
Test Report / Technical Construction File no. NYQTCF102002-LVD/EMC
Certificate’s
Holder:
Beijing Navilaser Technology Co., Ltd. # 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