APEX MEDICAL CORP.

APEX MEDICAL CORP.

Address:No. 9, MIN SHENG ST., TU-CHENG,NEW TAIPEI 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

Ventilator, Non-Continuous (Respirator) (BZD) (9) Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (5)

Premarket Exempt

No Yes

Clear

APEX - 04713025000011 Catalog Number :

Device Description : XT Fit

Device Class :

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000028 Catalog Number :

Device Description : XT Fit with Humidifier

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BTT, BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000035 Catalog Number :

Device Description : XT Sense

Device Class :

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000042 Catalog Number :

Device Description : XT Sense with Humidifier

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BTT, BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000059 Catalog Number :

Device Description : XT Prime

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000066 Catalog Number :

Device Description : XT Prime with Humidifier

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BTT, BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000073 Catalog Number :

Device Description : XT Auto

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000080 Catalog Number :

Device Description : XT Auto with Humidifier

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BTT, BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000097 Catalog Number :

Device Description : XT Humidifier

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

APEX - 04713025000103 Catalog Number :

Device Description : iCH Auto

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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