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PowerPrep™ Pathogen NA Extraction Kit EXP
EUDAMEDClass A (EU MDR)
Ref E0019SModel E0019, E0019S
Identity
- Trade Name
- PowerPrep™ Pathogen NA Extraction Kit EXP EUDAMED
- Device Name
- PowerPrep™ Pathogen NA Extraction Kit EXP EUDAMED
- Model / Reference
- E0019, E0019S EUDAMEDE0019S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800056300091 EUDAMED
- Basic UDI-DI
- 88000563E00195H 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™ Pathogen NA Extraction Kit EXP by KogeneBiotech Co., Ltd. — 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 | 88000563E00195H | 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 (2)
- EUDAMED 8ab5c728-bf3c-4e32-8e15-9e6ee3d298e7 61 fields · synced Jun 19, 2026
- EUDAMED 161352f6-0995-4d07-ba2d-dd69f140ac5c 61 fields · synced Jun 19, 2026