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Human Serum Albumin (HSA)
EUDAMEDFDA UDIClass III (EU MDR)
Ref 9988Model 9988-12x5mL
Identity
- Trade Name
- Human Serum Albumin (HSA) EUDAMEDHuman Serum Albumin (HSA)100mg/mL in Normal Saline FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Human Serum Albumin EUDAMEDHuman Serum Albumin (HSA)100mg/mL in Normal Saline. Not for Injection. FDA UDI
- Model / Reference
- 9988-12x5mL EUDAMEDFDA UDI9988 EUDAMED
- Description
- Human Serum Albumin (HSA)100mg/mL in Normal Saline. Not for Injection. FDA UDI
Identifiers
- Catalog Number
- 9988 FDA UDI
- Primary DI / UDI-DI
- 00810195240187 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810195240187 EUDAMED
- 510(k) Number
- K983584 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 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
Yes
EUDAMED
Human Tissues
Yes
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
Human Serum Albumin (HSA) 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-00810195240187 | 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 1934895f-04f3-43c1-96ab-0ab0bc1c8fa8 61 fields · synced Jun 19, 2026
- FDA UDI 2e80bc87-2dd9-4284-a446-06b2873d0c64 36 fields · synced May 29, 2026
- EUDAMED abd05b9f-b2ae-4acd-a77f-0a2b55c94b8a 61 fields · synced Jun 19, 2026