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NS Biotec blood cell counter
EUDAMEDClass IVD General (EU MDR)
Ref NS Biotec hema 21Model Hema 21
by Ns Biotec
Identity
- Trade Name
- NS Biotec blood cell counter EUDAMED
- Device Name
- Blood cell counter EUDAMED
- Model / Reference
- Hema 21 EUDAMEDNS Biotec hema 21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-Hema21XA EUDAMED
- Basic UDI-DI
- B-Hema21XA EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS 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-Hema21XA | 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 e3b3ce10-97ed-4958-8915-cb60b0a72d3e 61 fields · synced Jul 21, 2026