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cofoe

FDA UDI

Class I (US FDA UDI)

by Cofoe Medical Technology Co., Ltd.

Identity

Trade Name
cofoe FDA UDI
Generic Name
Multiple-piece intestinal ostomy bag, open-ended FDA UDI
Device Name
Two-piece Drainable IIeostomy Bag FDA UDI
Model / Reference
Two-piece Drainable IIeostomy Bag(08326V) FDA UDI
Description
Two-piece Drainable IIeostomy Bag FDA UDI

Identifiers

Primary DI / UDI-DI
06950715505601 FDA UDI
FDA Product Code
EZQ FDA UDI
GMDN Term
Multiple-piece intestinal ostomy bag, open-ended FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple-piece intestinal ostomy bag, open-ended

cofoe by Cofoe Medical Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-piece intestinal ostomy bag, open-ended.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cofoe Medical Technology Co., Ltd.

Sources (1)

  • FDA UDI 90fc3a4e-b9ee-40ba-9378-19379c591bb1 33 fields · synced May 31, 2026