Identity
- Trade Name
- Buffer EL EUDAMED
- Device Name
- Buffer EL EUDAMED
- Model / Reference
- 79218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053228046561 EUDAMED
- Basic UDI-DI
- 4053228RBEL00000000000172 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Buffer EL by QIAGEN GmbH — 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 | 4053228RBEL00000000000172 | Class A | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (1)
- EUDAMED a74fd166-4cce-4922-8b56-b07b491ba3d3 61 fields · synced Jun 18, 2026