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NucleoSpin® Dx RNA Blood
EUDAMEDClass A (EU MDR)
Ref 740201.50Model NucleoSpin® Dx RNA Blood
Identity
- Trade Name
- NucleoSpin® Dx RNA Blood EUDAMED
- Device Name
- NucleoSpin® Dx RNA Blood EUDAMED
- Model / Reference
- NucleoSpin® Dx RNA Blood EUDAMED740201.50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681169540 EUDAMED
- Basic UDI-DI
- 4046681169540YM EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
NucleoSpin® Dx RNA Blood by MACHEREY-NAGEL GmbH & Co. KG — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4046681169540YM | Class A | Active |
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Manufacturer
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005636
Sources (1)
- EUDAMED c3660633-d3df-467a-919b-6c9baefb2699 61 fields · synced Jun 20, 2026