Identity
- Device Name
- BLOODBANK EUDAMED
- Model / Reference
- FS25EA425PVS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059575290059 EUDAMED
- Basic UDI-DI
- 805957529FRIGOEMOTECHE3Y EUDAMED
- Direct Marketing DI
- 08059575290059 EUDAMED
- EMDN Code
- Z121701 BLOOD BANKS REFRIGERATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood refrigerator
The BLOODBANK device is a high-quality, automated blood bank system designed for clinical laboratory use. This device is compliant with FDA standards and is used to manage and process large quantities of blood products in a sterile environment.
Similar devices
Also classified as Blood refrigerator.
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- Cardinal Health Blood Bank Refrigerator — KEY SCIENTIFIC INC · Class II
- Horizon Series™ — HELMER Inc. · Class II
- BL 300 ULTIMATE E — Philipp Kirsch GmbH · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805957529FRIGOEMOTECHE3Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fri.med. S.r.l.
- EUDAMED SRN
- IT-MF-000028888
Sources (1)
- EUDAMED cd07439c-40fd-4bce-a6d9-201e08ac3b59 61 fields · synced Jul 21, 2026