Identity
- Trade Name
- MagCore® Giga Genomic DNA Kit EUDAMED
- Device Name
- MagCore® System EUDAMED
- Model / Reference
- GGD-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 34719890671289 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® Giga Genomic DNA 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 (1)
- EUDAMED c5749e5e-38b8-4bc2-8213-859f19e62e62 61 fields · synced Jun 18, 2026