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Blood Lipid Test Strip

FDA UDI

Class I (US FDA UDI)

by Urit Medical Electronic Co., Ltd.

Identity

Trade Name
Blood Lipid Test Strip FDA UDI
Generic Name
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI
Model / Reference
PFS 30,10strips/vial×2/box FDA UDI

Identifiers

Primary DI / UDI-DI
06935740726986 FDA UDI
FDA Product Code
CHH FDA UDI
LBR FDA UDI
JGY FDA UDI
MRR FDA UDI
GMDN Term
Multiple clinical chemistry analyte monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1175 FDA UDI
862.1475 FDA UDI
862.1705 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple clinical chemistry analyte monitoring system IVD, home-use

Blood Lipid Test Strip by Urit Medical Electronic Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyte monitoring system IVD, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urit Medical Electronic Co., Ltd.

Sources (1)

  • FDA UDI ded875ff-63e4-416b-91b2-59fc0ae550fe 33 fields · synced May 30, 2026