Auvon

FDA UDI

Class II (US FDA UDI)

by Shenzhen Yuwen E-Commerce Co., Ltd.

Identity

Trade Name: AUVON FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. FDA UDI
Model / Reference: TS3000001 FDA UDI
Description: The Draw-In blood glucose test strip is designed to provide an easy, accurate method for the determination of capillary whole blood glucose values. This analysis employs the enzyme glucose oxidase and is based on advanced biosensor technology that is specific for -D-glucose measurement. The test strips are designed in such a way that when the blood is applied to the edge of reaction zone, the glucose oxidase triggers the oxidation of glucose in the blood. The intensity of the electrons formed is measured by the meter and correlates well with the concentration of glucose in the blood sample. FDA UDI

Identifiers

Primary DI / UDI-DI: 06971292001607 FDA UDI
FDA Product Code: FMK FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Glucose monitoring system IVD, home-use

Auvon by Shenzhen Yuwen E-Commerce Co., Ltd. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Shenzhen Yuwen E-Commerce Co., Ltd.

Sources (1)

FDA UDI 40fc7bee-1feb-4d16-9b17-6055553cbe77 33 fields · synced May 31, 2026