Identity
- Trade Name
- Vivoo FDA UDI
- Generic Name
- Natural conception assistance kit FDA UDI
- Device Name
- 5-Strip HCG Pregnancy Tests, 25-Strip LH-Ovulation Test, and 30 Plastic Urine Cups FDA UDI
- Model / Reference
- VWHL25V1 FDA UDI
- Description
- 5-Strip HCG Pregnancy Tests, 25-Strip LH-Ovulation Test, and 30 Plastic Urine Cups FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011489160 FDA UDI
- 510(k) Number
- K233624 FDA UDI
- FDA Product Code
- LCX FDA UDINGE FDA UDI
- GMDN Term
- Natural conception assistance kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI862.1485 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Natural conception assistance kit
Vivoo by Vivosens Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Natural conception assistance kit.
- Dr. Talbot's — TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS LLC · Class I
- Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) — EASY HEALTHCARE CORPORATION · Class II
- Topcare — Topco Associates, LLC · Class I
- PREGABLE Ovulation Test Kit — Equinox Biotech Co., Ltd. · Class I
- DAVID — Equinox Biotech Co., Ltd. · Class I
- Smilereader ovulation test kit — Equinox Biotech Co., Ltd. · Class I
- Easy@Home Ovulation Test Strip (50 tests kit) — EASY HEALTHCARE CORPORATION · Class I
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vivosens Inc
Sources (1)
- FDA UDI 2fd57f49-88a0-4061-b568-94c5d4421d44 35 fields · synced May 30, 2026