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

Mattress, Air Flotation, Alternating Pressure (FNM) (5) Negative Pressure Wound Therapy Powered Suction Pump (OMP) (3) Bed, Flotation Therapy, Powered (IOQ) (2)

Premarket Exempt

No Yes

Clear

NA - 04713616090742 Catalog Number :

Device Description : Relief Aire LAL M-set 48'' × 84'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616090827 Catalog Number :

Device Description : VT．One Carrying Bag

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090841 Catalog Number :

Device Description : VT•100 SYS Global Lock Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616090858 Catalog Number :

Device Description : VT．One 60 Days SYS Global Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04713616091008 Catalog Number :

Device Description : Relief Aire LAL M-set 54'' × 80'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IOQ

Prescription Use : No

Device Count : 1

NA - 04713616091015 Catalog Number :

Device Description : TheraFlo M-set 35.5" × 83" AirBag QLT FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091084 Catalog Number :

Device Description : Airrapy Pillowed Air M-set Reg QLT FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091091 Catalog Number :

Device Description : Envelop M-set 35.5'' × 83'' QLT Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091107 Catalog Number :

Device Description : Envelop Bariatric M-Set 48" × 83" QLT Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091152 Catalog Number :

Device Description : ePhysio 13-14 Moderate M-set 36" x 80" QLT FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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