Identity
- Trade Name
- ExiStation™ FA DNA/RNA Kit (V2) EUDAMED
- Device Name
- ExiStation™ FA DNA/RNA Kit (V2) EUDAMED
- Model / Reference
- K-4814 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809537078603 EUDAMED
- Basic UDI-DI
- 880953707K4814BG 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
- Germany 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
Category: Nucleic acid extraction/isolation kit IVD
ExiStation™ FA DNA/RNA Kit (V2) by Bioneer Corporation — 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 | 880953707K4814BG | Class A | Active |
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Manufacturer
- Manufacturer
- BIONEER Corporation
- EUDAMED SRN
- KR-MF-000018672
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 743390e1-ddbb-4ebb-be5a-0cf3213b1770 61 fields · synced Jun 18, 2026