Identity
- Trade Name
- E-Prep Plus EUDAMED
- Device Name
- Sample Processing Instruments EUDAMED
- Model / Reference
- ALBCCZ002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800038500341 EUDAMED
- Basic UDI-DI
- 88000385CZHUROQ9 EUDAMED
- Direct Marketing DI
- 08800038500341 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
E-Prep Plus by CelltraZone 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 | 88000385CZHUROQ9 | Class A | Active |
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Manufacturer
- Manufacturer
- CelltraZone Co., Ltd
- EUDAMED SRN
- KR-MF-000026492
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED be9be759-4655-4ce3-932c-b4a3866bd2da 61 fields · synced Jul 9, 2026