Identity
- Trade Name
- HOS Test EUDAMEDFDA UDI
- Generic Name
- Osmolality IVD, reagent FDA UDI
- Device Name
- HOS Test EUDAMEDSperm vitality test The hypo-osmotic swelling test is a sperm vitality test based on the principle that live spermatozoa swell due to the absorption of a hypo-osmotic solution. The HOS test is based on the test procedure described in the WHO laboratory manual for the examination of human semen and sperm-cervical mucus interaction. For more information, visit the FertiPro website: www.fertipro.com FDA UDI
- Model / Reference
- HOST EUDAMEDFDA UDI
- Description
- Sperm vitality test The hypo-osmotic swelling test is a sperm vitality test based on the principle that live spermatozoa swell due to the absorption of a hypo-osmotic solution. The HOS test is based on the test procedure described in the WHO laboratory manual for the examination of human semen and sperm-cervical mucus interaction. For more information, visit the FertiPro website: www.fertipro.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967001873 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967HOST1Y5 EUDAMED
- Direct Marketing DI
- 05411967001873 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Osmolality IVD, reagent FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 20 Milliliter FDA UDI
HOS Test by FertiPro — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5411967HOST1Y5 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (2)
- EUDAMED 4d9bb20c-47e1-4f48-8401-dffab168a931 61 fields · synced Jun 18, 2026
- FDA UDI 25a43ed8-3ada-41f6-b11f-35de07350f77 36 fields · synced May 30, 2026