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ISolate Ready to Use Density Gradient Medium at Two Concentrations
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 99264Model 99264-2x100mL
Identity
- Trade Name
- ISolate Ready to Use Density Gradient Medium at Two Concentrations EUDAMEDISolate Ready to Use Density Gradient Medium FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- ISolate Ready to Use Density Gradient Medium at Two Concentrations EUDAMEDISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 1x100mL Upper Layer and 1x100mL Lower Layer. FDA UDI
- Model / Reference
- 99264-2x100mL EUDAMEDFDA UDI99264 EUDAMED
- Description
- ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 1x100mL Upper Layer and 1x100mL Lower Layer. FDA UDI
Identifiers
- Catalog Number
- 99264 FDA UDI
- Primary DI / UDI-DI
- 00810195240361 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240361 EUDAMED
- 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 IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
ISolate Ready to Use Density Gradient Medium at Two Concentrations by Irvine Scientific, Llc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00810195240361 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Irvine Scientific, LLC.
- EUDAMED SRN
- US-MF-000007514
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 9c1b6b67-47f4-49d2-b7b0-aa5e71152f33 61 fields · synced Jun 19, 2026
- FDA UDI af8d8b44-3d29-4b58-8b87-3d9a6497895c 35 fields · synced May 30, 2026
- EUDAMED 965bd14b-a96c-4870-b3db-5cd6dc6985df 61 fields · synced Jun 19, 2026