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Novodiag Instrument Rev. B Package
EUDAMEDClass A (EU MDR)
Ref NVD-INST-B-KRef R-NVD-INST-B-K
Identity
- Trade Name
- Novodiag Instrument Rev. B Package EUDAMEDReconditioned Novodiag Instrument Rev. B Package EUDAMED
- Device Name
- Novodiag System EUDAMED
- Model / Reference
- NVD-INST-B-K EUDAMEDR-NVD-INST-B-K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430041761570 EUDAMED06430041761662 EUDAMED
- Basic UDI-DI
- 643004176B0039MJ EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland 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
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
Novodiag Instrument Rev. B Package by Mobidiag Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 643004176B0039MJ | Class A | No Longer Active |
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Manufacturer
- Manufacturer
- Mobidiag Ltd.
- EUDAMED SRN
- FI-MF-000001215
Sources (2)
- EUDAMED 8d5be24a-81de-45cd-bade-4c9e64b18585 61 fields · synced Jul 27, 2026
- EUDAMED b7d446f6-898c-40df-b209-e668248f07a1 61 fields · synced May 18, 2026