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Automatic Digital Slice Scanning System
EUDAMEDClass A (EU MDR)
Ref IBL500Model IBL300Ref IBL 500Model IBL 200, IBL 400, IBL 700, IBL 006F, IBL 030F, IBL 060F, IBL 240F, IBL 480F, BL-006, BL-020, BL-040, BL-060, BL-200, BL-300, BL-400, BL-600, FL-006, FL-020, FL-040, FL-060, FL-200, FL-300, FL-400, FL-600
Identity
- Device Name
- Automatic Digital Slice Scanning System EUDAMEDDigital Slide Scanner for Pathology EUDAMED
- Model / Reference
- IBL300 EUDAMEDIBL500 EUDAMEDIBL 200, IBL 400, IBL 700, IBL 006F, IBL 030F, IBL 060F, IBL 240F, IBL 480F, BL-006, BL-020, BL-040, BL-060, BL-200, BL-300, BL-400, BL-600, FL-006, FL-020, FL-040, FL-060, FL-200, FL-300, FL-400, FL-600 EUDAMEDIBL 500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975767420016 EUDAMED
- Basic UDI-DI
- 697576742slicescanningMK EUDAMED697576742IBL0001RR EUDAMED
- Direct Marketing DI
- 06975767420016 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMEDW0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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 (2)
- EUDAMED 2996956e-9ef6-4c67-968f-cee0a2ad97cd 61 fields · synced Jun 19, 2026
- EUDAMED b98b6d95-dfc5-404d-8412-efebb93f554e 61 fields · synced Jun 19, 2026