Identity
- Trade Name
- TRUELINE R-300 EUDAMED
- Device Name
- CYBOW Reader 300 EUDAMED
- Model / Reference
- CYBOW Reader 300 EUDAMEDTA5200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806141303053 EUDAMED
- Basic UDI-DI
- 88061413UR6200H2 EUDAMED
- EMDN Code
- W02010701 URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Trueline R-300 by DFI 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 | 88061413UR6200H2 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DFI Co., Ltd.
- EUDAMED SRN
- KR-MF-000015786
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 07a38d11-f96a-48f9-8e76-cbe7385dce5b 61 fields · synced Jul 25, 2026