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Automatic Digital Slice Scanning System
EUDAMEDClass A (EU MDR)
Ref FL-040Model 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 EUDAMEDFL-040 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
- 06975767420221 EUDAMED
- Basic UDI-DI
- 697576742SliceScanning2U EUDAMED697576742IBL0001RR EUDAMED
- Direct Marketing DI
- 06975767420221 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 d02c2409-40f4-414d-8eb9-8d1a65ce7d2b 61 fields · synced Jul 8, 2026
- EUDAMED 922459b5-f999-44d0-a15a-35d502ebd811 61 fields · synced Jul 8, 2026