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ISolate Stock Solution
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 99275Model 99275-100mL
Identity
- Trade Name
- ISolate Stock Solution EUDAMEDFDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- ISolate Stock Solution EUDAMED90% Density Gradient Sperm Separation Medium FDA UDI
- Model / Reference
- 99275-100mL EUDAMEDFDA UDI99275 EUDAMED
- Description
- 90% Density Gradient Sperm Separation Medium FDA UDI
Identifiers
- Catalog Number
- 99275 FDA UDI
- Primary DI / UDI-DI
- 00810195240378 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240378 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
- Belgium 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
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
ISolate Stock Solution by Irvine Scientific, Llc — Class IIb — 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-00810195240378 | 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 (2)
- EUDAMED c37ebcaf-4aa5-4e13-833d-204e9146ff15 61 fields · synced May 30, 2026
- FDA UDI 7363aa24-8c02-4784-95d7-17a2704dd7e6 35 fields · synced May 30, 2026