Identity
- Trade Name
- B401 EUDAMED
- Device Name
- Blood bank refrigerators EUDAMED
- Model / Reference
- 991.8200.** EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05450104537189 EUDAMED
- Basic UDI-DI
- 05450104511059AW EUDAMED
- EMDN Code
- Z121701 BLOOD BANKS REFRIGERATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Luxembourg 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
B401 by B Medical Systems S.à r.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood refrigerator.
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- i.Series® — HELMER Inc. · Class II
- Horizon Series™ — HELMER Inc. · Class II
- Cardinal Health Blood Bank Refrigerator — KEY SCIENTIFIC INC · Class II
- Horizon Series™ — HELMER Inc. · Class II
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 | 05450104511059AW | Class IIa | Active |
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Manufacturer
- Manufacturer
- B Medical Systems S.à r.l.
- EUDAMED SRN
- LU-MF-000000128
Sources (1)
- EUDAMED 0de9a09c-bea1-4353-87b7-632bf4313b04 61 fields · synced Jun 18, 2026