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SpermMar Test IgG Negative Control
EUDAMEDFDA UDIClass B (EU MDR)
Ref SPMG_N
by FertiPro
Identity
- Trade Name
- SpermMar Test IgG Negative Control EUDAMEDSpermMar IgG Negative Control FDA UDI
- Generic Name
- Sperm antibody IVD, control FDA UDI
- Device Name
- SpermMar Test IgG Negative Control EUDAMEDSpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be found on the FertiPro website: www.fertipro.com FDA UDI
- Model / Reference
- SPMG_N EUDAMEDFDA UDI
- Description
- SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm Antibodies (SpermMar IgG). More information can be found on the FertiPro website: www.fertipro.com FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967001361 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967SPMGN12N EUDAMED
- Direct Marketing DI
- 05411967001361 EUDAMED
- FDA Product Code
- KTO FDA UDI
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
- GMDN Term
- Sperm antibody IVD, control 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
Yes
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 — 2.5 Milliliter FDA UDI
SpermMar Test IgG Negative Control 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 | 5411967SPMGN12N | 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 b521a684-616b-4505-97ed-0640b31bbe06 61 fields · synced Jun 20, 2026
- FDA UDI c7b0d307-b57b-4936-838e-ab3f9eb0c58a 36 fields · synced May 30, 2026