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MagCore® EDA Automated Nucleic Acid Extractor and Assay Setup
EUDAMEDClass A (EU MDR)
Ref MDA4802
Identity
- Trade Name
- MagCore® EDA Automated Nucleic Acid Extractor and Assay Setup EUDAMED
- Device Name
- MagCore® System EUDAMED
- Model / Reference
- MDA4802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719890670069 EUDAMED
- Basic UDI-DI
- 471989067M0000A9 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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® EDA Automated Nucleic Acid Extractor and Assay Setup 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 (1)
- EUDAMED 62a4ae39-f5d4-402a-b6e1-cb503d1d683a 61 fields · synced Jul 16, 2026