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) (10)

Premarket Exempt

No Yes

Clear

NA - 04713616092203 Catalog Number :

Device Description : Airrapy Pillowed Air-set Reg Aeotex FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092210 Catalog Number :

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

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092227 Catalog Number :

Device Description : TheraFlo AP P.U. US

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092234 Catalog Number :

Device Description : Airrapy Blower P.U. US FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092241 Catalog Number :

Device Description : Airrapy Blower RC US 110V 50/60 Hz FMP

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092371 Catalog Number :

Device Description : Envelop P.U. US Global Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092418 Catalog Number :

Device Description : Relief Aire APM 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 - 04713616092425 Catalog Number :

Device Description : Relief Aire APM 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 - 04713616092432 Catalog Number :

Device Description : Relief Aire APM M-set 42'' × 80'' QLT H&R

Device Class : 2

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

NA - 04713616092449 Catalog Number :

Device Description : ePhysio 10-12 Elevated 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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