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Freezing Medium - Test Yolk Buffer (TYB) with Glycerol and Gentamicin
EUDAMEDFDA UDIClass III (EU MDR)
Ref 90128Model 90128-20x5mL
Identity
- Trade Name
- Freezing Medium - Test Yolk Buffer (TYB) with Glycerol and Gentamicin EUDAMEDFreezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Freezing Medium - Test Yolk Buffer (TYB) with Glycerol and Gentamicin EUDAMEDFreezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin FDA UDI
- Model / Reference
- 90128-20x5mL EUDAMEDFDA UDI90128 EUDAMED
- Description
- Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin FDA UDI
Identifiers
- Catalog Number
- 90128 FDA UDI
- Primary DI / UDI-DI
- 00810195240163 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240163 EUDAMED
- 510(k) Number
- K991421 FDA UDI
- FDA Product Code
- MQL FDA UDI
- EMDN Code
- U08020501 MATERIALS/SOLUTIONS FOR FREEZING/THAWING 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
- 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
Yes
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
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
Freezing Medium - Test Yolk Buffer (TYB) with Glycerol and Gentamicin by Irvine Scientific, Llc — Class III — 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-00810195240163 | 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 (3)
- EUDAMED 5a75d121-fbf0-4e53-a681-958691a77606 61 fields · synced Jul 16, 2026
- FDA UDI 762e07bd-60e7-4b7c-95e8-438b2656796c 36 fields · synced May 30, 2026
- EUDAMED 0a6b568d-24be-4d90-a8b1-e4d66303bfec 61 fields · synced Jul 16, 2026