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NucleoSpin® Dx Blood
EUDAMEDClass A (EU MDR)
Ref 740899.50Model NucleoSpin® Dx BloodRef 740899.250
Identity
- Trade Name
- NucleoSpin® Dx Blood EUDAMED
- Device Name
- NucleoSpin® Dx Blood EUDAMED
- Model / Reference
- NucleoSpin® Dx Blood EUDAMED740899.50 EUDAMED740899.250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046681006302 EUDAMED04046681006319 EUDAMED
- Basic UDI-DI
- 4046681151026VX 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
No
EUDAMED
NucleoSpin® Dx 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 | 4046681151026VX | Class A | Active |
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Manufacturer
- Manufacturer
- MACHEREY-NAGEL GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005636
Sources (2)
- EUDAMED 2c324a49-307d-4952-8bd7-0eb57ce88d9d 61 fields · synced Oct 6, 2026
- EUDAMED f46ced4e-f339-43c1-be20-fc98ff8da89f 61 fields · synced May 16, 2026