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NS Biotec blood cell counter
EUDAMEDClass IVD General (EU MDR)
Ref NS Biotec blood cell counter hema 25Model Hema 25
by Ns Biotec
Identity
- Trade Name
- NS Biotec blood cell counter EUDAMED
- Device Name
- Blood cell counter EUDAMED
- Model / Reference
- Hema 25 EUDAMEDNS Biotec blood cell counter hema 25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Hema25XJ EUDAMED
- Basic UDI-DI
- B-Hema25XJ EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) 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
NS Biotec blood cell counter by Ns Biotec — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Blood cell counter
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-Hema25XJ | 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 f5f9a620-fccc-48d5-b1d5-b93a7c3bb48c 61 fields · synced Jun 18, 2026