Identity
- Trade Name
- Maxwell® CSC XtractAll FFPE DNA/RNA Kit EUDAMED
- Device Name
- Maxwell® CSC XtractAll FFPE DNA/RNA Kit EUDAMED
- Model / Reference
- AS1560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00849811083778 EUDAMED
- Basic UDI-DI
- 08498110837784W EUDAMED
- EMDN Code
- W02060185 ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Maxwell® CSC XtractAll FFPE DNA/RNA Kit by Promega Corporation — 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 | 08498110837784W | Class A | Active |
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Manufacturer
- Manufacturer
- Promega Corporation
- EUDAMED SRN
- US-MF-000034520
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 094d929d-3500-484c-b45e-bb67e63d9d86 61 fields · synced Jun 19, 2026