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NS BIOTEC Chemistry Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref SCA 1000/1200Model NS BIOTEC Chemistry Analyzer
by Ns Biotec
Identity
- Trade Name
- NS BIOTEC Chemistry Analyzer EUDAMED
- Device Name
- NS BIOTEC Chemistry Analyzer EUDAMED
- Model / Reference
- NS BIOTEC Chemistry Analyzer EUDAMEDSCA 1000/1200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ChemistryAnalyzerHC EUDAMED
- Basic UDI-DI
- B-ChemistryAnalyzerHC EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) 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 Chemistry Analyzer by Ns Biotec — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: sca 1000
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-ChemistryAnalyzerHC | 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 547d0d75-d131-41bd-b0cc-0cd732916127 61 fields · synced Jun 17, 2026