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SpermMar Test IgA Single kit
EUDAMEDFDA UDIClass B (EU MDR)
Ref SPMA_S
by FertiPro
Identity
- Trade Name
- SpermMar Test IgA Single kit EUDAMEDSpermMar Test IgA - single kit FDA UDI
- Generic Name
- Sperm antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- SpermMar Test IgA Single kit EUDAMEDSpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class. The Spermar Test IgA is a diagnostic kit for detecting antisperm antibodies of the IgA class in human semen. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction. More information can be found at the FertiPro website: www.fertipro.com FDA UDI
- Model / Reference
- SPMA_S EUDAMEDFDA UDI
- Description
- SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class. The Spermar Test IgA is a diagnostic kit for detecting antisperm antibodies of the IgA class in human semen. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction. More information can be found at the FertiPro website: www.fertipro.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967002566 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967SPMAS127 EUDAMED
- Direct Marketing DI
- 05411967002566 EUDAMED
- FDA Product Code
- KTO FDA UDI
- EMDN Code
- W0102109013 SPERM ANTIBODIES EUDAMED
- GMDN Term
- Sperm antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.5530 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
Yes
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 — 0.7 Milliliter FDA UDI
SpermMar Test IgA Single kit 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 | 5411967SPMAS127 | 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 4afb4acf-2d07-4c8a-bed7-da4c82f1d6d3 61 fields · synced Jul 11, 2026
- FDA UDI 1a3ed3cf-04e2-4658-8b50-fc92a554b8a1 36 fields · synced May 30, 2026