Identity
- Trade Name
- RealBest UniMag Universal NA Extraction Kit EUDAMED
- Device Name
- RealBest UniMag EUDAMED
- Model / Reference
- CE8883 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04606974008668 EUDAMED
- Basic UDI-DI
- 460697400002BW 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
- Latvia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
RealBest UniMag Universal NA Extraction Kit by AO Vector-Best — 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 | 460697400002BW | Class A | Active |
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Manufacturer
- Manufacturer
- AO Vector-Best
- EUDAMED SRN
- RU-MF-000037499
- Authorised Representative
- BIORON GmbH DE-AR-000022984
Sources (1)
- EUDAMED bbe0b28b-ee8a-4bfd-ab7d-c71eff0a9d1a 61 fields · synced Jul 15, 2026