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Modified HTF Medium-HEPES with Gentamicin
EUDAMEDFDA UDIClass III (EU MDR)
Ref 90126Model 90126-100mLModel 90126-500mL
Identity
- Trade Name
- Modified HTF Medium-HEPES with Gentamicin EUDAMEDModified HTF Medium with Gentamicin FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Modified HTF Medium - HEPES with Gentamicin EUDAMEDModified HTF Medium-HEPES with Gentamicin EUDAMEDModified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement. FDA UDIModified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement. FDA UDI
- Model / Reference
- 90126-100mL EUDAMEDFDA UDI90126 EUDAMED90126-500mL EUDAMEDFDA UDI
- Description
- Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement. FDA UDIModified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement. FDA UDI
Identifiers
- Catalog Number
- 90126 FDA UDI
- Primary DI / UDI-DI
- 00810195240422 EUDAMEDFDA UDI00810195240439 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240422 EUDAMEDB-00810195240439 EUDAMED
- 510(k) Number
- K983586 FDA UDI
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U08020502,U08020503 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
- 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
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
Modified HTF Medium-HEPES with Gentamicin by Irvine Scientific, Llc — 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-00810195240422 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | 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 (6)
- EUDAMED acbd5227-adaa-4390-8f44-ac2ad0ca375a 61 fields · synced Jul 24, 2026
- EUDAMED 83da7329-f90c-43a6-89d2-795e0b906e31 61 fields · synced May 17, 2026
- FDA UDI 4e62a6a6-1072-49a5-8fc5-31ab5d609d5e 36 fields · synced May 30, 2026
- FDA UDI e6bc25a0-ccf9-4f53-bba2-a07b7360e3eb 36 fields · synced May 30, 2026
- EUDAMED d8599387-60f8-49a3-9da3-1cd89ac54ff8 61 fields · synced Jul 12, 2026
- EUDAMED e4014a23-c0da-413b-aad1-c6b09e21f683 61 fields · synced Jul 24, 2026