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MagSi-DX Pathogen Plus
EUDAMEDClass A (EU MDR)
Ref MDDX00030960Ref MDDX00030096
Identity
- Trade Name
- MagSi-DX Pathogen Plus EUDAMED
- Device Name
- MagSi-DX Pathogen Plus EUDAMED
- Model / Reference
- MDDX00030960 EUDAMEDMDDX00030096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260350320104 EUDAMED04260350320111 EUDAMED
- Basic UDI-DI
- 426035032DX0003PL EUDAMED
- Direct Marketing DI
- 04260350320104 EUDAMED04260350320111 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
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
MagSi-DX Pathogen Plus by magtivio B.V. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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 | 426035032DX0003PL | Class A | Active |
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Manufacturer
- Manufacturer
- magtivio B.V.
- EUDAMED SRN
- NL-MF-000023114
Sources (2)
- EUDAMED 533c80ad-0dca-45a0-9dd0-15105cd9ec82 61 fields · synced Jul 31, 2026
- EUDAMED 1e4756ac-5e19-4ba5-b383-aa5eb710ab81 61 fields · synced May 18, 2026