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CURO L5 Meter

FDA UDI

Class I (US FDA UDI)

by OSANG HEALTHCARE Co., Ltd.

Identity

Trade Name
CURO L5 Meter FDA UDI
Generic Name
Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid FDA UDI
Model / Reference
ILM-0001A FDA UDI

Identifiers

Primary DI / UDI-DI
08809115905406 FDA UDI
FDA Product Code
CHH FDA UDI
JGY FDA UDI
GMDN Term
Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1175 FDA UDI
862.1705 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid

CURO L5 Meter by OSANG HEALTHCARE Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OSANG HEALTHCARE Co., Ltd.

Sources (1)

  • FDA UDI 10108fe6-cf96-4b9c-9d00-e5fea66e35b9 34 fields · synced May 30, 2026