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Guangyi

FDA UDI

Class I (US FDA UDI)

by Jiangsu Guangyi Medical Dressing Co., LTD.

Identity

Trade Name
GUANGYI FDA UDI
Generic Name
Cast/bandage waterproof bathing cover, single-use FDA UDI
Model / Reference
PU, 15cm*10m FDA UDI

Identifiers

Primary DI / UDI-DI
06974692680007 FDA UDI
FDA Product Code
MHW FDA UDI
GMDN Term
Cast/bandage waterproof bathing cover, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5075 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cast/bandage waterproof bathing cover, single-use

Guangyi by Jiangsu Guangyi Medical Dressing Co., LTD. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cast/bandage waterproof bathing cover, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 3a5309fe-34b3-4979-8c38-1f57dabc655e 32 fields · synced Jun 1, 2026