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

Bed, Flotation Therapy, Powered (IOQ) (5) Mattress, Air Flotation, Alternating Pressure (FNM) (4) Negative Pressure Wound Therapy Powered Suction Pump (OMP) (1)

Premarket Exempt

No Yes

Clear

NA - 04713616091701 Catalog Number :

Device Description : Relief Aire LAL Cover 48'' × 84'' QLT H&R-1P

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091725 Catalog Number :

Device Description : Relief Aire LAL Cover 54'' × 84'' QLT H&R-1P

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091732 Catalog Number :

Device Description : TheraFlo P.U. US Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091800 Catalog Number :

Device Description : Relief Aire LAL Standard P.U. US H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091817 Catalog Number :

Device Description : Relief Aire LAL Bariatric P.U. US H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091879 Catalog Number :

Device Description : AVA LAL P.U. US Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091916 Catalog Number :

Device Description : Digital flow meter

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092012 Catalog Number :

Device Description : VT．One SYS Global Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616092104 Catalog Number :

Device Description : Entrix NX P.U. US Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092197 Catalog Number :

Device Description : Airrapy Bairrapy M-set 47'' × 83'' QLT FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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