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) (7) Mattress, Flotation Therapy, Non-Powered (IKY) (2) Cushion, Flotation (KIC) (1)

Premarket Exempt

No Yes

Clear

NA - 04713616092494 Catalog Number :

Device Description : Dual P.U. US Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092500 Catalog Number :

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

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092517 Catalog Number :

Device Description : ePhysio 10-12 Elevated P.U. US FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092555 Catalog Number :

Device Description : Lagniappe M-set 35.5" x 83" QLT Comp Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092562 Catalog Number :

Device Description : ePhysio 13-14 Moderate P.U. US FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092616 Catalog Number :

Device Description : Entrina P.U. US Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092647 Catalog Number :

Device Description : ePhysio 15 + Intervention P.U. US FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092685 Catalog Number :

Device Description : Relief Max M-set 36'' × 80'' TDX H&R

Device Class : 1

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

NA - 04713616092692 Catalog Number :

Device Description : Relief Cushion C-Set 16 x 20" TDX H&R

Device Class : 1

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

NA - 04713616092708 Catalog Number :

Device Description : Relief Max Cover 36'' × 80'' TDX H&R-1p

Device Class : 1

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

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