Identity
- Trade Name
- PowerEXP™ 48LH EUDAMED
- Device Name
- PowerEXP™ 48LH EUDAMED
- Model / Reference
- KE4800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800056348000 EUDAMED
- Basic UDI-DI
- 88000563KE48005Y EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
PowerEXP™ 48LH by KogeneBiotech Co., Ltd. — 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 | 88000563KE48005Y | 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 2a557bdb-3a7e-45b3-89fa-477ed3645d41 61 fields · synced Aug 2, 2026