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MagCore® NGS Auto Size-Select purification Kit
EUDAMEDClass A (EU MDR)
Ref MNC-01Ref MNC-02
Identity
- Trade Name
- MagCore® NGS Auto Size-Select purification Kit EUDAMED
- Device Name
- MagCore® System EUDAMED
- Model / Reference
- MNC-01 EUDAMEDMNC-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 34719890671258 EUDAMED14719890671254 EUDAMED
- Basic UDI-DI
- 471989067M0000A9 EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
MagCore® NGS Auto Size-Select purification Kit by RBCBioscience Corp. — 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 | 471989067M0000A9 | Class A | Active |
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Manufacturer
- Manufacturer
- RBCBioscience Corp.
- EUDAMED SRN
- TW-MF-000026757
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 552d3211-4cde-4e32-bfdf-721c5c311b88 61 fields · synced Jul 31, 2026
- EUDAMED e1648227-f69f-4df5-b483-0d07831d0f38 61 fields · synced May 18, 2026