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Emdyca

Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsLaser surgery instruments

Multi-platform laser

EMDN code Z12011019

17 manufacturers, 116 models including 111 on the market, 10 countries

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Manufacturers registered in Europe (EUDAMED) 17
  • On the market
  • No longer marketed
  • 93/42 Former directive, not yet certified under the MDR
  • Click a manufacturer to see its full range, a model to open its EUDAMED record.
ManufacturerCountryRegistered modelsClassContact
Quanta System FDA Italy
39 others
IIb 93/42 regulatory@quantasystem.com EUDAMED record Report an error
Deka Italy
13 others
IIb MDR, 93/42 Website info@deka.it EUDAMED record Report an error
Cutera FDA EU representative : MDSS GmbH (Germany) United States
6 others
IIb MDR, 93/42 Website info@cutera.com EUDAMED record Report an error
Lumenis FDA EU representative : Lumenis (Germany) GmbH (Germany) Germany, Israel
5 others
IIb MDR Website info.germany@lumenis.com EUDAMED record Report an error
Fotona FDA Slovenia
2 others
IIb MDR, 93/42 info@fotona.com EUDAMED record Report an error
waveguide medical systems Austria IIb 93/42 Website info@waveguide-medical.com EUDAMED record Report an error
Candela FDA EU representative : AR Experts B.V. (Netherlands) United States IIb 93/42 EUDAMED record Report an error
Lutronic FDA EU representative : Emergo Europe B.V. (Netherlands) South Korea
1 other
IIb MDR, 93/42 EUDAMED record Report an error
BTL Industries FDA EU representative : BTL ITALIA S.r.l. (Italy) United Kingdom (ex Northern Ireland) IIb MDR EUDAMED record Report an error
Globalipl FDA EU representative : MedNet EC-REP C IIb GmbH (Germany) China IIb MDR EUDAMED record Report an error
Lynton EU representative : Advena Limited (Malta) United Kingdom (ex Northern Ireland) IIb 93/42 Website info@lynton.co.uk EUDAMED record Report an error
A.R.C. Laser FDA Germany IIb MDR Website info@arclaser.de EUDAMED record Report an error
Adss FDA EU representative : Prolinx GmbH (Germany) China IIa MDR EUDAMED record Report an error
Apolo FDA EU representative : Lotus NL B.V. (Netherlands) China IIb 93/42 EUDAMED record Report an error
Fisioline FDA Italy IIb 93/42 Website EUDAMED record Report an error
SIA "LINLINE Medical Systems" Latvia IIb 93/42 EUDAMED record Report an error
Zhengzhou PZ Laser Slim Technology FDA EU representative : MedPath GmbH (Germany) China IIb MDR EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 1

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

ManufacturerCountryBrandsFDA clearance
ATENA (FROM THE IMCO GROUP) LTD Israel – registered

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