FDA UDI
In Commercial Distribution
🇺🇸 United States
Surearly SMART
DI: 08809408863499
·
Model: Surearly SMART (SSMD001E)
·
Sugentech Inc._Osong Branch
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Surearly SMART
- Primary DI
- 08809408863499
- Version / Model
- Surearly SMART (SSMD001E)
- Company Name
- Sugentech Inc._Osong Branch
- Labeler DUNS
- 694860936
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-15
- Public Version
- 1
- Public Version Date
- 2025-05-23
- Public Version Status
- New
- Public Device Record Key
- 92f50e63-1844-43f3-8151-cb8df69815e2
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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NGA | Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Clinical Chemistry | 862.1300 | 1 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Clinical Chemistry | 862.1485 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809408863499 | GS1 |
Customer Contacts
- Phone
- 1-800-526-0943
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight, moisture and heat.