AccessGUDID - DEVICE: Surearly SMART (08809408863499)

GUDID

Device Identifier (DI) Information

Brand Name: Surearly SMART
Version or Model: Surearly SMART (SSMD001E)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sugentech Inc._Osong Branch

Primary DI Number: 08809408863499
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694860936 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65860	Immunoassay reagent vehicle reader IVD	A portable, electrically-powered device intended to be used to receive and display results and/or errors from an assay performed on an immunoassay reagent vehicle (e.g., test strip, cassette, cartridge, or card). It is a rechargeable unit with multiple slots and display screens. It does not perform liquid handling, analysis, or analyte detection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter
NGE	Test, Luteinizing Hormone (Lh), Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 2 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep away from direct sunlight, moisture and heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 92f50e63-1844-43f3-8151-cb8df69815e2
Public Version Date: May 23, 2025
Public Version Number: 1
DI Record Publish Date: May 15, 2025