EUDAMED device

Human Serum Albumin (HSA)

EUDAMED device 00810195240187 · Irvine Scientific, LLC.

Key facts

Primary DI 00810195240187
Trade name Human Serum Albumin (HSA)
Device name Human Serum Albumin
Reference or catalog number 9988
Model 9988-12x5mL
Manufacturer Irvine Scientific, LLC.
Manufacturer SRN US-MF-000007514
Risk class Class III
EMDN code U08020502
EMDN description MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION
Legislation mdd
Implantable No
Sterile Yes
Single use Yes
Status date Jul 15, 2025

At a glance

  • Yes Matching FDA GUDID record

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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