Los Deline | Injectable Volumizing Implant - Certification

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Los Deline® Grants of Protection

REGISTRATION, CERTIFICATION, INTELLECTUAL PROPERTY

 

All manufacturing processes are carried out strictly according to the requirements

of the manufacturing of medical devices Class III

by GMP and ISO standards.

 

LOS DELINE® products certificates:

 

  

EC CERTIFICATE According to Annex II of the Directive 93/42/EEC on Medical Devices

Full Quality Assurance System no.: 2195-MED-1820101

EC DESIGN EXAMINATION CERTIFICATE no.: 2195-MED-1820101-D01

     
 

ISO 13485:2016 (MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM) no.: 31820101

The certificates were valid form 20.07.2018 till 02.05.2023.
From 23.03.2023 BIOTRH s.r.o. did not produce product with CE mark an did not supply the product to the European market.

 

 

 

Technology of LOS DELINE® manufacturing is covered
by patent CZ №31571

 

LOS DELINE® has a CERTIFICATE OF FREE SALE № 00007771
issued by State Institute for Drug Control CZ

 

LOS DELINE®, 

®

has World Intellectual Property Organization (WIPO) protection.

 

   International Registration Numbers:

№ 1 395 260 priopity date: 27.11.2017
№ 1 398 158 priopity date: 27.11.2017

 

LOS DELINE™ is protected in countries:

 

 Europe:

Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Italy,
Ireland, Latvia, Lithuania, Luxembourg,
Malta, Norway, Netherlands, Poland, Portugal,
Romania, Serbia, Slovakia, Slovenia, Spain,
Sweden, Turkey, Ukraine, United Kingdom,
Switzerland, Russian Federation.

Asia: Japan, Republic of Korea, China, Turkey,
Israel, Hong Kong, Singapore, Philippines,
Indonesia, India.
America: USA, Mexico, Colombia, Chile, Canada
Africa: Morocco, Republic of South Africa.
Australasia: 
Australia, New Zealand.