Copioumed

FDA UDI

Class I (US FDA UDI)

by Copioumed International Inc.

Identity

Trade Name: Copioumed FDA UDI
Generic Name: Shoe cover FDA UDI
Device Name: Copioumed’s Spunbond Shoe Covers offer a protective covering for shoes worn in the healthcare facility. They help minimize contamination and prevent the transmission of microorganisms between staff and patients and hospital-acquired complications. FDA UDI
Model / Reference: SHN0B101-1 FDA UDI
Description: Copioumed’s Spunbond Shoe Covers offer a protective covering for shoes worn in the healthcare facility. They help minimize contamination and prevent the transmission of microorganisms between staff and patients and hospital-acquired complications. FDA UDI

Identifiers

Primary DI / UDI-DI: 04719882250620 FDA UDI
FDA Product Code: BWP FDA UDI
GMDN Term: Shoe cover FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Shoe cover

Copioumed by Copioumed International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Copioumed International Inc.

Sources (1)

FDA UDI 7b325834-bdeb-4c67-8cee-c4f55b75fd6e 34 fields · synced Jun 8, 2026