COPIOUMED INTERNATIONAL INC.

Address:16F-4, No.1, Fuxing North Road,TAIPEI Taiwan,CN

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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

Accessory, Surgical Apparel (LYU) (1) Cover, Shoe, Operating-Room (FXP) (1) Drape, Surgical, Exempt (PUI) (1) Garment, Protective, For Incontinence (EYQ) (1) Gown, Examination (FME) (1) Gown, Isolation, Surgical (FYC) (1) Suit, Surgical (FXO) (1)

Premarket Exempt

No Yes

Clear

Copioumed - 04719882250767 Catalog Number :

Device Description : Copioumed's patient gowns are protective clothing made for patients to protect p Copioumed's patient gowns are protective clothing made for patients to protect patients from bacterial infections.

Device Class :

Duns Number: 658318113

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 10

Copioumed - 04719882250804 Catalog Number :

Device Description : Copioumed’s scrub suits are protective outfits made for medical personnel for us Copioumed’s scrub suits are protective outfits made for medical personnel for use in operating rooms when they might come in touch with an infectious substance or body fluid.

Device Class :

Duns Number: 658318113

Premarket Exempt : Yes

Product Code : FXO

Prescription Use : No

Device Count : 10

Copioumed - 04719882250897 Catalog Number :

Device Description : Copioumed's surgical drape can effectively block the penetration of bodily fluid Copioumed's surgical drape can effectively block the penetration of bodily fluids during surgery, prevent cross-infection, and maintain a sterile field at the surgical site.

Device Class :

Duns Number: 658318113

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Copioumed - 04719882250910 Catalog Number :

Device Description : Copioumed’s Isolation Gown is intended to protect health care patients and healt Copioumed’s Isolation Gown is intended to protect health care patients and health care personal from the transfer of microorganisms, body fluids and particulate material.Isolation Gown is a single use, disposable medical device provided non-sterile.

Device Class :

Duns Number: 658318113

Premarket Exempt : No

Product Code : FYC

Prescription Use : No

Device Count : 10

Copioumed - 14719882250603 Catalog Number :

Device Description : Copioumed’s Non-woven Apron provides barrier protection against fluids and other Copioumed’s Non-woven Apron provides barrier protection against fluids and other contaminants.

Device Class :

Duns Number: 658318113

Premarket Exempt : Yes

Product Code : LYU

Prescription Use : No

Device Count : 100

Copioumed - 14719882250870 Catalog Number :

Device Description : Copioumed’s Protective Shoe Cover is used by medical personnel in medical instit Copioumed’s Protective Shoe Cover is used by medical personnel in medical institutions to prevent contact with potentially infectious patient blood, body fluids, secretions, etc., and play a barrier and protection role.

Device Class : 1

Duns Number: 658318113

Premarket Exempt : No

Product Code : FXP

Prescription Use : No

Device Count : 200

Copioumed - 14719882250887 Catalog Number :

Device Description : Copioumed's Examination gown is a device for medical purposes, made of SMS mater Copioumed's Examination gown is a device for medical purposes, made of SMS material, that is draped or worn by the patient as a body covering during medical examinations. Provides patient protection from contamination by microorganisms, body fluids and particles.

Device Class : 1

Duns Number: 658318113

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 50

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