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FertiCult Mineral Oil
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref MINOIL500
by FertiPro
Identity
- Trade Name
- FertiCult Mineral Oil EUDAMEDFDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- FertiCult Mineral Oil, FertiCult High Viscosity Oil EUDAMEDFertiCult™ Mineral Oil - MINOIL500 (500ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com) FDA UDI
- Model / Reference
- MINOIL500 EUDAMEDFDA UDI
- Description
- FertiCult™ Mineral Oil - MINOIL500 (500ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967000081 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967OIL13M EUDAMED
- 510(k) Number
- K053494 FDA UDI
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
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 — 500 Milliliter FDA UDI
FertiCult Mineral Oil by FertiPro — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5411967OIL13M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- FertiPro
- EUDAMED SRN
- BE-MF-000000313
Sources (2)
- EUDAMED e370595d-cfdd-45eb-bea2-dfd930d5dad9 61 fields · synced May 30, 2026
- FDA UDI 89bc7060-dcf4-4eb6-a055-9ff3e833fb19 37 fields · synced May 30, 2026