HSINER CO., LTD.

Address:312, Jhongshang Rd., Shengang Dist.,TAICHUNG CITY,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

Filter, Bacterial, Breathing-Circuit (CAH) (2) Ventilator, Non-Continuous (Respirator) (BZD) (2) Condenser, Heat And Moisture (Artificial Nose) (BYD) (1)

Premarket Exempt

No Yes

Clear

Hsiner - 04712688051439 Catalog Number : 10285

Device Description : Twin-port CPAP mask, (w/o headgear)

Device Class : 2

Duns Number: 657310868

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Hsiner - 04712688051460 Catalog Number : 10243

Device Description : COMFO CPAP Silicone Face mask set, size: S

Device Class : 2

Duns Number: 657310868

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Hsiner - 04712688052979 Catalog Number : 70544

Device Description : Pleated HME REF70544

Device Class : 1

Duns Number: 657310868

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : Yes

Device Count : 1

Hsiner - 04712688057431 Catalog Number : 70530

Device Description : B/V Filter REF 70530

Device Class : 2

Duns Number: 657310868

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

Hsiner - 04712688057448 Catalog Number : 70531

Device Description : HMEF REF70531

Device Class : 2

Duns Number: 657310868

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

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