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FertiCult High Viscosity Oil
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HVOIL100P
by FertiPro
Identity
- Trade Name
- FertiCult High Viscosity Oil EUDAMEDFDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- FertiCult Mineral Oil, FertiCult High Viscosity Oil EUDAMEDFertiCult High Viscosity Oil - HVOIL100P (100ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral oil (d=0.86-0.88g/ml) for use in In Vitro Fertilization (IVF), Intracytoplasmatic Sperm Injection (ICSI) and Assisted reproductive technologies (ART). 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
- HVOIL100P EUDAMEDFDA UDI
- Description
- FertiCult High Viscosity Oil - HVOIL100P (100ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral oil (d=0.86-0.88g/ml) for use in In Vitro Fertilization (IVF), Intracytoplasmatic Sperm Injection (ICSI) and Assisted reproductive technologies (ART). 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
- 05411967000487 EUDAMEDFDA UDI
- Basic UDI-DI
- 5411967OIL13M EUDAMED
- FDA Product Code
- QKI 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter FDA UDI
FertiCult High Viscosity 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 eb7b1da5-b6ed-4f7e-9324-e3b599fd633e 61 fields · synced Jul 31, 2026
- FDA UDI 3f32c94d-d3b7-4413-aba4-dae45dd33d0c 36 fields · synced May 30, 2026