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MagCore® Genomic DNA Whole Blood Kit (Speedy installation)
EUDAMEDClass A (EU MDR)
Ref MGB400-05Ref MGB400-03Ref MGB400-01
Identity
- Trade Name
- MagCore® Genomic DNA Whole Blood Kit (Speedy installation) EUDAMEDMagCore® Genomic DNA Whole Blood Kit EUDAMED
- Device Name
- MagCore® System EUDAMED
- Model / Reference
- MGB400-05 EUDAMEDMGB400-03 EUDAMEDMGB400-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 54719890671009 EUDAMED34719890671012 EUDAMED34719890671005 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
Category: Nucleic acid extraction/isolation kit IVD
MagCore® Genomic DNA Whole Blood Kit (Speedy installation) by RBCBioscience Corp. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
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- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 (3)
- EUDAMED 1d61bd3d-dc17-48ff-9db5-9dc720ec7180 61 fields · synced Oct 6, 2026
- EUDAMED e2b73b73-9afa-44fd-bb62-e392acbdd1e8 61 fields · synced May 17, 2026
- EUDAMED cfbd6d9d-de8a-467c-b181-04cf0024995c 61 fields · synced May 18, 2026