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Automatic Digital Slice Scanning System
EUDAMEDClass A (EU MDR)
Ref IBL 200Model 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
- IBL 200 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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975767420054 EUDAMED
- Basic UDI-DI
- 697576742SliceScanning2U EUDAMED697576742IBL0001RR EUDAMED
- Direct Marketing DI
- 06975767420054 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 | 697576742SliceScanning2U | 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 1ca90225-4654-497d-baa0-70ce653b965e 61 fields · synced Jul 13, 2026
- EUDAMED 0b6f5932-de71-484d-8933-03aa7caa7383 61 fields · synced Jul 13, 2026