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Sources: EU EUDAMED, US FDA
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Country: Switzerland
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The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
FDA Enforcement
Class II
·Terminated·SIE AG, Surgical Instrument Engineering·April 4, 2018
SIE AG, Surgical Instrument Engineering
System producer
🇨🇭 Switzerland
CO-RE I 8xthousand
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
CO-RE I Welcome CN
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
CO-RE II 8xthousand
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
CO-RE II Welcome EU
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
OneTouch Select Plus Flex
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·LifeScan Europe GmbH·1 device
Consumable Kit 3
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
Consumable Kit 2
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
VFV CONSUMABLE KIT ML STAR, NIMBUS and VANTAGE
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hamilton Bonaduz AG·1 device
TECO® Fast Cryptococcus neoformans Ag Lateral Flow Assay
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
TECO® Fast Aspergillus Galactomannan Ag Lateral Flow Assay
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
TECO® Fast Candida Mannan Antigen Lateral Flow Assay
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
OneTouch Select Plus Flex
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·LifeScan Europe GmbH·1 device
TECO® Fungus (1-3)-β-D-Glucan Assay
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
TECO® Aspergillus Galactomannan ELISA kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
TECO® Hyaluronic Acid PLUS ELISA kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
TECO® Human Leptin ELISA kit
Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
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Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device
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Basic UDI-DI
EU IVDD
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Eu Ivd General
·TECOmedical AG·1 device