Identity
- Trade Name
- MagnisDx NGS Prep System EUDAMED
- Device Name
- MagnisDx NGS Prep System EUDAMED
- Model / Reference
- K1007A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700574036850 EUDAMED
- Basic UDI-DI
- 570057R0802P3011A040500SJ EUDAMED
- Direct Marketing DI
- 05700574036850 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
MagnisDx NGS Prep System by Agilent Technologies Singapore (International) Pte Ltd — 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 | 570057R0802P3011A040500SJ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- SG-MF-000014448
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED 31077010-0ab7-460f-94cf-a1df4cab4991 61 fields · synced Oct 6, 2026