Hygitech

FDA UDI

Class I (US FDA UDI)

by Hygitech

Identity

Trade Name: HYGITECH FDA UDI
Generic Name: Shoe cover FDA UDI
Device Name: Non-woven overshoes HYGITECH Reference: HY-50017 Standard: Non-woven One size fits all FDA UDI
Model / Reference: HY-50017 FDA UDI
Description: Non-woven overshoes HYGITECH Reference: HY-50017 Standard: Non-woven One size fits all FDA UDI

Identifiers

Catalog Number: HY-50017 FDA UDI
Primary DI / UDI-DI: 03615140003285 FDA UDI
FDA Product Code: FXP 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

Yes

FDA UDI

Category: Shoe cover

Hygitech by Hygitech — 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: Hygitech

Sources (1)

FDA UDI 8ce21bf3-cc32-4f4e-bfb8-1a33c1aca938 34 fields · synced May 30, 2026