LEEHO ITC-PROJEKT PRODUKT

Manufacturer

🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices

PLASTIC SPECTACLE FRAMES WITHOUT LENSES

Device

EU MDR · Eu Md Class 1 ·LEEHO ITC-PROJEKT PRODUKT·On the market·32 countries

METAL AND PLASTIC SPECTACLE FRAMES WITHOUT LENSES

Device

EU MDR · Eu Md Class 1 ·LEEHO ITC-PROJEKT PRODUKT·On the market·32 countries

METAL SPECTACLE FRAMES WITHOUT LENSES

Device

EU MDR · Eu Md Class 1 ·LEEHO ITC-PROJEKT PRODUKT·On the market·13 countries

Glasses Frame Acetate

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LEEHO ITC-PROJEKT PRODUKT·1 device

Glasses Frame Titanium+Acetate

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LEEHO ITC-PROJEKT PRODUKT·1 device

Glasses Frames Titanium

Basic UDI-DI

EU MDR · Eu Md Class 1 ·LEEHO ITC-PROJEKT PRODUKT·1 device

Simedice Biotechnologies Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·1 Importer·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Henan Simedice Biotechnologies Co.,Ltd.

Manufacturer

🇨🇳 China·3 Basic UDI-DIs·3 Devices·1 Importer·DEKRA Certification B.V. and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC

Device

EU MDD · Eu Md Class 2b ·Henan Simedice Biotechnologies Co.,Ltd.·On the market·1 country

IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC

Device

EU MDD · Eu Md Class 2b ·Simedice Biotechnologies Inc.·On the market·1 country

FI20/00010

Certificate

MDD Annex II (excluding section 4)·Leltek Inc.·DNV Product Assurance AS·2 Basic UDI-DIs

FI2000010

Certificate

MDD Annex II Section 4·Leltek Inc.·SGS FIMKO OY·1 Basic UDI-DI

TW19/20030

Certificate

MDD Annex II (excluding section 4)·Somnics, Inc.·SGS Belgium NV·2 Basic UDI-DIs

M.2021.106.14254

Certificate

MDD Annex II (excluding section 4)·Henan Simedice Biotechnologies Co.,Ltd.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

M.2021.106.14179

Certificate

MDD Annex II (excluding section 4)·Simedice Biotechnologies Inc.·UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.·1 Basic UDI-DI

41315215

Certificate

MDD Annex II (excluding section 4)·Nova Eye, Inc.·INTERTEK SEMKO AB·2 Basic UDI-DIs

160841CE01

Certificate

MDD Annex II (excluding section 4)·NP Medical, Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

2005 12 0495 CT

Certificate

IVDD Annex IV (excluding sections 4, 6)·MedMira Laboratories Inc.·CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS·6 Basic UDI-DIs

FI20/07011

Certificate

MDD Annex II (excluding section 4)·QT Medical, Inc.·SGS FIMKO OY·1 Basic UDI-DI