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PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0
EUDAMEDClass A (EU MDR)
Ref E0016
Identity
- Trade Name
- PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 EUDAMED
- Device Name
- PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 EUDAMED
- Model / Reference
- E0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800056300015 EUDAMED
- Basic UDI-DI
- 88000563E00165B 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
- Czechia 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
PowerPrep™ Viral DNA/RNA Extraction Kit Ver.1.0 by KogeneBiotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
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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 | 88000563E00165B | Class A | Active |
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Manufacturer
- Manufacturer
- KogeneBiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000045858
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED e46d7df4-ddbb-4a62-bd70-aad0f587cefb 61 fields · synced Jun 20, 2026