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Automatic Digital Slice Scanning System
EUDAMEDClass A (EU MDR)
Ref IBL300 Model IBL300
Identity
- Device Name
- Automatic Digital Slice Scanning System EUDAMED
- Model / Reference
- IBL300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975767420009 EUDAMED
- Basic UDI-DI
- 697576742slicescanningMK EUDAMED
- Direct Marketing DI
- 06975767420009 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
Automatic Digital Slice Scanning System by Suzhou Betrue Technology 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 | 697576742slicescanningMK | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou Betrue Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039348
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (1)
- EUDAMED 900261d3-5c6d-485a-af81-52223159ac6d 61 fields · synced Jun 18, 2026