← Back to catalogue

Surearly SMART

FDA UDI

Class I (US FDA UDI)

by Sugentech Inc._Osong Branch

Identity

Trade Name
Surearly SMART FDA UDI
Generic Name
Immunoassay reagent vehicle reader IVD FDA UDI
Device Name
Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc. in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the Surearly SMART App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed. FDA UDI
Model / Reference
Surearly SMART (SSMD001E) FDA UDI
Description
Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc. in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the Surearly SMART App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed. FDA UDI

Identifiers

Primary DI / UDI-DI
08809408863499 FDA UDI
FDA Product Code
NGA FDA UDI
NGE FDA UDI
GMDN Term
Immunoassay reagent vehicle reader IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1300 FDA UDI
862.1485 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Immunoassay reagent vehicle reader IVD

Surearly SMART by Sugentech Inc._Osong Branch — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sugentech Inc._Osong Branch

Sources (1)

  • FDA UDI 92f50e63-1844-43f3-8151-cb8df69815e2 35 fields · synced May 30, 2026