CONTAMAC HOLDINGS LIMITED

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Lens, Contact (Other Material) - Daily (HQD) (9) Lens, Contact (Orthokeratology) (MUW) (4)

Premarket Exempt

Clear

Optimum Extra - 00865576000201 Catalog Number : roflufocon D

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD, MUW

Prescription Use : Yes

Device Count : 1

Optimum Extreme - 00865576000218 Catalog Number : roflufocon E

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD, MUW

Prescription Use : Yes

Device Count : 1

Optimum Comfort - 00865576000225 Catalog Number : roflufocon C

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

Optimum Classic - 00865576000232 Catalog Number : roflufocon A

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

Optimum HR 1.51 - 00865576000249 Catalog Number : hirafocon A

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

Optimum HR 1.53 - 00865576000256 Catalog Number : hirafocon B

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

Hybird FS - 00865576000270 Catalog Number : hybufocon A

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

HEXA100 - 00865576000287 Catalog Number : hexafocon A

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD, MUW

Prescription Use : Yes

Device Count : 1

Optimum Infinite - 00865576000294 Catalog Number : Tisilfocon A

Device Description : Rigid Gas Permeable Contact Lens

Device Class : 2

Duns Number: 216236887

Premarket Exempt : No

Product Code : HQD, MUW

Prescription Use : Yes

Device Count : 1

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