Identity
- Trade Name
- PurePrep Pathogen DGX EUDAMED
- Device Name
- MagSi-DX Pathogen EUDAMED
- Model / Reference
- OE00380096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260350320050 EUDAMED
- Basic UDI-DI
- 426035032DX0001PG 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
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
PurePrep Pathogen DGX by magtivio B.V. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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 | 426035032DX0001PG | Class A | Active |
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Manufacturer
- Manufacturer
- magtivio B.V.
- EUDAMED SRN
- NL-MF-000023114
Sources (1)
- EUDAMED c8d708ba-553f-42d9-8622-7a4c4c0fcb20 61 fields · synced Jun 19, 2026