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) (6) Cushion, Flotation (KIC) (4)

Premarket Exempt

No Yes

Clear

NA - 04713616091169 Catalog Number :

Device Description : Signa Relief P.U. US H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091176 Catalog Number :

Device Description : Dyno/Signa Relief M-set 36'' × 80'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091183 Catalog Number :

Device Description : Dyno/Signa Relief M-set 36'' × 84'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091190 Catalog Number :

Device Description : ePhysio 15+ Intervention 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

NA - 04713616091206 Catalog Number :

Device Description : Dyno Relief P.U. US H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616091237 Catalog Number :

Device Description : Relief Chair Cover 180 × 50cm TDX H&R-1p

Device Class : 1

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

NA - 04713616091299 Catalog Number :

Device Description : Relief Chair C-set 180 × 50cm TDX H&R

Device Class : 1

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

NA - 04713616091305 Catalog Number :

Device Description : Cari Chair P.U. Global Carilex

Device Class : 1

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

NA - 04713616091312 Catalog Number :

Device Description : Relief Chair P.U. Global H&R

Device Class : 1

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

NA - 04713616091329 Catalog Number :

Device Description : CozinyPlus P.U. Global H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

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