Identity
- Trade Name
- V-GRAD 80 EUDAMEDFDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- V-GRAD 80 EUDAMEDV- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures. FDA UDI
- Model / Reference
- V-GRD83_100G EUDAMEDV-GRD83_100P EUDAMEDFDA UDI
- Description
- V- GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes. It is intended for separation of motile sperm from ejaculates for use in assisted reproduction procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260531791570 EUDAMED04260531791549 EUDAMED04260650071102 FDA UDI
- Basic UDI-DI
- B-04260531791570 EUDAMEDB-04260531791549 EUDAMED
- 510(k) Number
- K241833 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 III EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
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
V-Grad 80 by VITROMED GmbH — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260531791570 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- VITROMED GmbH
- EUDAMED SRN
- DE-MF-000005131
Sources (3)
- EUDAMED 4b06aec3-a1e6-4344-b0db-bb11cec5a08c 61 fields · synced Jul 19, 2026
- EUDAMED 55a80c59-1d9a-4ec5-acbe-28ac688f8eb0 61 fields · synced May 19, 2026
- FDA UDI b432b09a-6549-497e-a78b-bfd54cbf65fb 34 fields · synced May 30, 2026