CARILEX MEDICAL, INC.

CARILEX MEDICAL, INC.

Address:No. 77, Keji 1st Rd.,Guishan District Taoyuan,TW

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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

Negative Pressure Wound Therapy Powered Suction Pump (OMP) (8) Bed, Flotation Therapy, Powered (IOQ) (2)

Premarket Exempt

No Yes

Clear

NA - 00471987369297 Catalog Number :

Device Description : TheraFlo 9 M-set 90 x 200cm WDTX Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616090179 Catalog Number :

Device Description : VT•100/VT•200 Bed Hanger

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090186 Catalog Number :

Device Description : VT•100/VT•200 IV Pole Hanger

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090209 Catalog Number :

Device Description : VT•100 SYS Global Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090216 Catalog Number :

Device Description : VT•200 SYS Global Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090223 Catalog Number :

Device Description : VT Dressing Kit S Carilex

Device Class :

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090230 Catalog Number :

Device Description : VT Dressing Kit M Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090247 Catalog Number :

Device Description : VT Dressing Kit L Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090285 Catalog Number :

Device Description : VT•100 Suitcase

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090322 Catalog Number :

Device Description : TheraFlo M-set 36'' × 80'' DTX Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

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