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Blood Bank Refrigerator
EUDAMEDClass IVD General (EU MDR)
Ref BDS-450RModel Blood Bank Refrigerator
by Ns Biotec
Identity
- Trade Name
- Blood Bank Refrigerator EUDAMED
- Model / Reference
- Blood Bank Refrigerator EUDAMEDBDS-450R EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-BloodBankRefrigeratorFF EUDAMED
- Basic UDI-DI
- B-BloodBankRefrigeratorFF EUDAMED
- EMDN Code
- Z121701 BLOOD BANKS REFRIGERATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Category: Blood refrigerator
Blood Bank Refrigerator by Ns Biotec — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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- Horizon Series™ — HELMER Inc. · Class II
Manufacturer's product page: Blood Bank Refrigerator
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-BloodBankRefrigeratorFF | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ns Biotec
- EUDAMED SRN
- EG-MF-000032515
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 7889fc28-1f01-4814-80a9-5a5b41876228 61 fields · synced Jun 18, 2026