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Spermac Stain A - 250 ml
EUDAMEDFDA UDIClass A (EU MDR)
Ref SPS250AModel SPS050 / SPS250
by FertiPro
Identity
- Trade Name
- Spermac Stain A - 250 ml EUDAMEDSpermac Stain - Stain A (250ml) FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Spermac Stain EUDAMEDSpermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of staining spermatozoa is to be able to differentiate morphologically normal from abnormal sperm cells. For more information, visit the FertiPro website: www.fertipro.com FDA UDI
- Model / Reference
- SPS050 / SPS250 EUDAMEDSPS250A EUDAMEDFDA UDI
- Description
- Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of staining spermatozoa is to be able to differentiate morphologically normal from abnormal sperm cells. For more information, visit the FertiPro website: www.fertipro.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967001583 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967SPS169 EUDAMED
- Direct Marketing DI
- 05411967001583 EUDAMED
- FDA Product Code
- LED FDA UDI
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 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 — 250 Milliliter FDA UDI
Spermac Stain A - 250 ml by FertiPro — Class A — 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 | 5411967SPS169 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (2)
- EUDAMED db50a89e-438f-49a6-a72c-a3e0d7628565 61 fields · synced Jun 20, 2026
- FDA UDI 18d08903-da38-42ce-81f8-0ea71f66bab6 36 fields · synced May 30, 2026