BioTechLogic Lithuania
Lithuanian medical and laser technology, precision optics and devices for export.
Lithuania has a world-class cluster of laser and photonics companies. BioTechLogic Lithuania produces medical devices, laser systems, and precision optical instruments, benefiting from Vilnius University's physics tradition. The company exports laser and medical technology products to Europe, the US, and Japan.
- Type
- Manufacturer
- Location
- Vilnius, Lithuania
- Founded
- 2007
- Website
- btl.lt
- Categories
- Medical & Healthcare Supplies, Electrical & Power Equipment
- Markets
- Germany, United States, United Kingdom, Japan, France
Claimed certifications
- 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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)