Identity
- Trade Name
- Oil for Embryo Culture EUDAMEDFDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Oil for Embryo Culture EUDAMEDSterile light mineral oil. 100mL bottle. FDA UDI
- Model / Reference
- 9305-100mL EUDAMEDFDA UDI
- Description
- Sterile light mineral oil. 100mL bottle. FDA UDI
Identifiers
- Catalog Number
- 9305 FDA UDI
- Primary DI / UDI-DI
- 00810195240217 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240217 EUDAMED
- 510(k) Number
- K011938 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 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
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
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
Oil for Embryo Culture 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-00810195240217 | 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 db38bfcc-9daf-4199-bb0a-f0e28bedb7d1 61 fields · synced Aug 1, 2026
- FDA UDI b93250bb-2378-466e-ad1c-a597df59ac84 36 fields · synced May 29, 2026
- EUDAMED 1c6c8631-5c23-485c-a58b-2b66faad1f43 61 fields · synced Aug 1, 2026