Identity
- Trade Name
- twoplus Applicator FDA UDI
- Generic Name
- Home-use artificial insemination kit FDA UDI
- Device Name
- An at home intravaginal insemination system to deliver semen to the vaginal canal for insemination. FDA UDI
- Model / Reference
- HC01 FDA UDI
- Description
- An at home intravaginal insemination system to deliver semen to the vaginal canal for insemination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08881300389024 FDA UDI
- 510(k) Number
- K232579 FDA UDI
- FDA Product Code
- QYZ FDA UDI
- GMDN Term
- Home-use artificial insemination kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6110 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home-use artificial insemination kit
twoplus Applicator by Hannah Life Technologies Pte Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hannah Life Technologies Pte Ltd
Sources (1)
- FDA UDI b74d03d9-55df-4a88-aa1d-5a9ae619fbf8 34 fields · synced Jun 8, 2026