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MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-32
EUDAMEDClass A (EU MDR)
Ref MGX-32
Identity
- Trade Name
- MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-32 EUDAMED
- Device Name
- Magnetic Bead-Based Automated NA Extraction System - MGX-32 EUDAMED
- Model / Reference
- MGX-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684998275996 EUDAMED
- Basic UDI-DI
- 868459503MGX32QC EUDAMED
- EMDN Code
- W02050399 NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER 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
No
EUDAMED
Reagent
No
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
MagPro™ Magnetic Bead-Based Automated NA Extraction System - MGX-32 by Vitrosens Biotechnology Inc. — Class A — IVDR — listed in EUDAMED
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 | 868459503MGX32QC | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 2a8aec0d-de5f-4a97-af52-464991b7ac1a 61 fields · synced Jul 12, 2026