BGEcare Non-sterile Non-woven Sponge

FDA UDI

Class I (US FDA UDI)

by Henan Zhende Medical Products Co., Ltd.

Identity

Trade Name: BGEcare Non-sterile Non-woven Sponge FDA UDI
Generic Name: Non-woven gauze pad, non-sterile FDA UDI
Device Name: BGEcare Non-sterile Non-woven Sponge 4"X4", 4-Ply, 200 pieces/pack, 10 packs/carton box FDA UDI
Model / Reference: NS0604040420010NS FDA UDI
Description: BGEcare Non-sterile Non-woven Sponge 4"X4", 4-Ply, 200 pieces/pack, 10 packs/carton box FDA UDI

Identifiers

Primary DI / UDI-DI: 06972403420133 FDA UDI
FDA Product Code: FRL FDA UDI
GMDN Term: Non-woven gauze pad, non-sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5300 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

Yes

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: Non-woven gauze pad, non-sterile

BGEcare Non-sterile Non-woven Sponge by Henan Zhende Medical Products Co., Ltd. — 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: Henan Zhende Medical Products Co., Ltd.

Sources (1)

FDA UDI e1f24b86-7910-4b51-89c6-0f454b78eae9 33 fields · synced Jun 8, 2026