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) (10)

Premarket Exempt

No Yes

Clear

APEX - 04713025000110 Catalog Number :

Device Description : iCH Prime

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000127 Catalog Number :

Device Description : iCH Sense

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000134 Catalog Number :

Device Description : iCH Auto

Device Class :

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000141 Catalog Number :

Device Description : iCH Prime

Device Class :

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000158 Catalog Number :

Device Description : iCH Sense

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000516 Catalog Number :

Device Description : Nasal Mask with Headgear (L)

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000523 Catalog Number :

Device Description : Nasal Mask with Headgear (M)

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000530 Catalog Number :

Device Description : Nasal Mask with Headgear (S)

Device Class :

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000547 Catalog Number :

Device Description : Nasal Mask with Headgear (XS)

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

APEX - 04713025000554 Catalog Number :

Device Description : Full Face Mask with Headgear (L)

Device Class : 2

Duns Number: 656413127

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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